Senior Clinical Research Associate - southern Germany
Clinical research associate job in Delaware
We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
Responsibilities
What You Will Be Doing:
Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
Qualifications
Your Profile:
Advanced degree in a relevant field such as life sciences, nursing, or medicine.
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
Life assurance
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
*****************************************************
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!
Auto-ApplySenior Clinical Operations Training Professional
Clinical research associate job in Dover, DE
**Become a part of our caring community and help us put health first** The Senior Clinical Operations Training Professional provides training support (both virtual and onsite) and implements organizational processes and programs to ensure new hires to the organization, along with, the staff and facilities in emerging markets are fully prepared for successful operations. This role includes an opportunity to travel to new and existing clinics across the US and participate in go-live support.
The Senior Clinical Operations Training Professional collaborates with training colleagues, market leadership, clinical and non-clinical associates throughout the organization. Secures needed resources and establishes/verifies key performance indicators to ensure readiness. Leads the transition to ongoing operational processes. Understands department, segment, and organizational strategy and operating objectives, including their linkages to related areas to connect the dots within the market. Follows established guidelines/procedures. Makes decisions on moderately complex to complex issues regarding technical approach for project components and work is performed with minimal direction. Has advanced level knowledge and a deep understanding of clinical workflows. Will conduct in-person, classroom, one on one and virtual learning sessions for care team members.
**Use your skills to make an impact**
**Required Qualifications**
+ Clinical and operational experience in a healthcare facility.
+ Five or more years training experience in a clinical setting to include electronic medical record implementation
+ Experience providing training and support virtually
+ Strong written and verbal communication skills
+ Strong customer service skills
+ Prior experience with delivering presentations to all levels of leadership.
+ Demonstrated ability to translate analytics into action and use the data to impact and influence business outcomes.
+ Microsoft Office proficiency - able to write queries, create forms, reports, presentations, and documents in Word, Power Point, Access and Excel
**Preferred Qualifications**
+ Bachelor's Degree
+ eCW and/or Athena EMR experience
+ Understanding of Value Based Care model
**Additional Information**
+ Travel required up to 75% of the time. Work from home when not traveling.
+ Strong preference incumbent live near a PCO market in the following states: GA, TX, NC, SC, IN, KY, FL, AZ, MS, LA, TN, KS, VA, MO
Travel: While this is a remote position, occasional travel to Humana's offices for training or meetings may be required.
**Scheduled Weekly Hours**
40
**Pay Range**
The compensation range below reflects a good faith estimate of starting base pay for full time (40 hours per week) employment at the time of posting. The pay range may be higher or lower based on geographic location and individual pay will vary based on demonstrated job related skills, knowledge, experience, education, certifications, etc.
$78,400 - $107,800 per year
This job is eligible for a bonus incentive plan. This incentive opportunity is based upon company and/or individual performance.
**Description of Benefits**
Humana, Inc. and its affiliated subsidiaries (collectively, "Humana") offers competitive benefits that support whole-person well-being. Associate benefits are designed to encourage personal wellness and smart healthcare decisions for you and your family while also knowing your life extends outside of work. Among our benefits, Humana provides medical, dental and vision benefits, 401(k) retirement savings plan, time off (including paid time off, company and personal holidays, volunteer time off, paid parental and caregiver leave), short-term and long-term disability, life insurance and many other opportunities.
Application Deadline: 11-29-2025
**About us**
About CenterWell Senior Primary Care: CenterWell Senior Primary Care provides proactive, preventive care to seniors, including wellness visits, physical exams, chronic condition management, screenings, minor injury treatment and more. Our unique care model focuses on personalized experiences, taking time to listen, learn and address the factors that impact patient well-being. Our integrated care teams, which include physicians, nurses, behavioral health specialists and more, spend up to 50 percent more time with patients, providing compassionate, personalized care that brings better health outcomes. We go beyond physical health by also addressing other factors that can impact a patient's well-being.
About CenterWell, a Humana company: CenterWell creates experiences that put patients at the center. As the nation's largest provider of senior-focused primary care, one of the largest providers of home health services, and fourth largest pharmacy benefit manager, CenterWell is focused on whole-person health by addressing the physical, emotional and social wellness of our patients. As part of Humana Inc. (NYSE: HUM), CenterWell offers stability, industry-leading benefits, and opportunities to grow yourself and your career. We proudly employ more than 30,000 clinicians who are committed to putting health first - for our teammates, patients, communities and company. By providing flexible scheduling options, clinical certifications, leadership development programs and career coaching, we allow employees to invest in their personal and professional well-being, all from day one.
**Equal Opportunity Employer**
It is the policy of Humana not to discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or protected veteran status. It is also the policy of Humana to take affirmative action, in compliance with Section 503 of the Rehabilitation Act and VEVRAA, to employ and to advance in employment individuals with disability or protected veteran status, and to base all employment decisions only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment.
Centerwell, a wholly owned subsidiary of Humana, complies with all applicable federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, sex, sexual orientation, gender identity or religion. We also provide free language interpreter services. See our full accessibility rights information and language options *************************************************************
Clinical Research Assistant
Clinical research associate job in Wilmington, DE
The Clinical Research Assistant is responsible for coordinating, implementing and completing clinical research studies or clinical trials with the Orthogenetics Department at Nemours Children's Hospital Delaware. The job includes but is not limited to: developing protocols, recruiting patients, assisting in budget and documents preparation, in-servicing research teams, recruiting patients, obtaining patient consents, educating patients, conducting study procedures, collecting data, keeping records, performing analysis, and assisting in manuscript / abstract preparation.
A high level of organization with attention to detail and the ability to manage multiple responsibilities is required. This position will work with multiple departments and must maintain a high level of professionalism and a continuous process improvement mindset.
The Clinical Research Assistant will be required to complete Human Subjects Protection (HSP) training and CITI training (including Good Clinical Practice (GCP).
Required skills include ability to work with children, experience with computer data entry, good verbal and written communication, and skills with Microsoft WORD, EXCEL and ADOBE.
Essential Functions:
Follows all aspects of Good Clinical Practices in the conduct of clinical research; assists in identifying, reporting, and following up on Serious Adverse Events.
Assists in protocol preparation; assists in budget development; prepares documents as required by sponsoring agencies; develops source documents; develops consent and assent documents; prepares IRB memoranda.
Attends investigator meetings, as assigned; interacts with representatives of sponsoring agencies.
In-services staff for study purposes.
Recruits patients.
Develops strategies to assure study subject compliance with protocol requirements.
Coordinates protocol activities; prepares clinical specimens for shipment to central laboratories.
Performs clinical data gathering and measurements.
Maintains study medication accountability records; maintains databases; assists in data analysis and manuscript / abstract preparation.
Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
Assists with stipend requests for patients.
Additional miscellaneous duties and responsibilities, as may be assigned from time to time by management.
Qualifications:
At least 1 year clinical research experience
Associate Degree is required (or in lieu of associate degree, two years of clinical research experience is required)
Effectively uses Microsoft computer software
Demonstrates ability to coordinate and establish priorities among diverse tasks
Effectively communicates verbally and in writing
Auto-ApplyClinical Project Manager 4
Clinical research associate job in Newark, DE
United States Newark, DE, United States Marlborough, MA, United States Join the Breast and Skeletal Health Clinical Affairs team as a **Clinical Project Manager,** leading major US and global clinical trials across multiple phases of medical device development. You'll ensure studies are executed on-time, on-budget, and with the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs, Program Management, Legal, Marketing, and Operations to deliver world-class evidence supporting breast and skeletal health technologies. We would prefer to have someone in Newark, DE or Marlborough, MA but open to Remote.
**Key Responsibilities:**
+ Lead planning and execution of complex clinical studies from protocol design to study closure, ensuring adherence to budget, scope, and schedule.
+ Coordinate cross-functional clinical teams (monitoring, data management, statistics, medical writing, medical monitoring, safety) for timely and proper project completion.
+ Develop and manage advanced clinical programs supporting product development and evidence generation.
+ Ensure all studies comply with domestic and international regulations and standards (GCP, ICH).
+ Build and manage high-performing clinical operations frameworks and teams.
+ Partner with Clinical Development on study design and reporting.
+ Create, review, and maintain study documents (protocols, informed consent, manuals, eCRFs, IRB submissions, IDE applications).
+ Select and oversee CROs and vendors, including contract negotiations and activity management from award to close-out.
+ Manage clinical budgets and pricing strategies using cost models.
+ Contribute expertise to strategic study design discussions and cross-functional planning.
+ Support regulatory filings and interactions; prepare documentation for product files (e.g., MDR Clinical Evaluation Reports).
+ Maintain division research records on domestic and international databases (e.g., ClinicalTrials.gov).
+ Lead annual Sunshine Act reporting and ensure documentation is catalogued in quality management systems.
**Physical Demands:**
+ Ability to sit and use hands for computer and office equipment.
+ Ability to travel up to 25%.
**Qualifications:**
+ Bachelor's or Master's Degree required; advanced degree (Master's, PhD) preferred.
+ 8+ years clinical research/operations experience (6+ years with Master's, 3+ years with PhD).
+ Experience in academic-industrial partnerships and with sponsors or CROs in the medical device industry.
+ Proven track record managing complex clinical studies and trials.
+ Experience in breast cancer screening, diagnostics, and treatment preferred.
+ Deep understanding of medical device regulations, GCP, clinical terminology, workflows, and trial design.
+ Excellent oral, written, and presentation skills; able to communicate across diverse stakeholder groups.
+ Strong interpersonal skills, attention to detail, and deadline-driven.
+ Strategic thinker with outstanding organizational and project management abilities.
+ Collaborative, adaptable, and able to manage multiple priorities in a matrixed environment.
**So why join Hologic?**
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!
The annualized base salary range for this role is $116,500 - $182,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
LI-#DS1
Clinical Territory Associate
Clinical research associate job in Wilmington, DE
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, lets advance the world of minimally invasive care.
Job Description
* Please note: Candidates must live within or be willing to relocate to the Wilmington, DE Area to perform the duties of this role.
Primary Function of Position
The Clinical Territory Associate (CTA) is a 24+ month developmental role that will partner with the Rehoboth Beach, DE team to gain knowledge in all aspects of our business to include technical, clinical, and sales.
Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)
* Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management
* Guides technical in-services for customers to include OR staff, surgeons, etc.
* Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas
* Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position
* Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports
Qualifications
Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job)
* Minimum 1-year leadership (military) experience or 1 year of outside sales experience required
* Ability to travel up to 25%, and work nights and weekends as needed
Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job)
* Bachelor's degree required
Working Conditions (As applicable - Any physical requirements for the job. If not applicable, state "none")
* None
Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)
* Proven record of success
* Ambition and exceptional work ethic
* Ability to excel in a high-energy, fast-paced environment
* Excellent interpersonal skills and persuasive communication skills
* Proven ability to work effectively as part of a team
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Mandatory Notices
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay + commission, benefits, and equity. The on target earnings for this position are listed.
Director / Senior Director, Clinical Research Scientist
Clinical research associate job in Wilmington, DE
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary The clinical scientist will provide scientific, clinical, and operational input to early and late stage clinical development programs.
This role will work on cross-functional study teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication.
Key Responsibilities Development of protocols for clinical studies.
Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
Monitor, review and summarize safety and efficacy data in ongoing studies.
Represent clinical development on project teams.
Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies.
Serve as liaison to project teams, CRO's, Clinical sub-teams, and others.
Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest.
Qualifications Degree in scientific/life-sciences field.
Pharm.
D.
or Ph.
D.
preferred.
Minimum of 5 years of drug development experience are required.
Alternative drug development experience will be considered.
Prior Dermatology or immunology experience is preferred.
Ability to work independently, multi-task, and work in a fast-paced environment.
Excellent written and oral communication skills.
Strong Analytical ability.
Ability to accommodate up to 20% travel or as business dictates Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.
Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.
You can learn more about this process here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
Trial Master File (TMF) Specialist Oncology
Clinical research associate job in Dover, DE
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.
**Key Responsibilities**
+ Responsible for overall quality, maintenance, and completeness of Trial Master Files.
+ Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues.
+ Develop project specific TMF plan and structure and update the plan as needed.
+ Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained.
+ Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.
+ Act as a liaison between the Site IRBs and study team to resolve queries and concerns.
+ Provide study team reports or updates regarding status of TMF on a regular basis.
+ Participate in audits and provide documents as requested.
+ Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings.
+ Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings.
+ Champion best practices for building and maintaining TMF health.
**Professional Experience / Qualifications**
+ BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings
+ Knowledge of and direct experience with Trial Master Files.
+ Prior eTMF (e.g. Veeva) administration required.
+ Strong Microsoft Office skills required.
+ Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2).
+ Fundamental knowledge of the conduct of clinical trials is preferred.
+ Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Clinical Research Assistant
Clinical research associate job in Wilmington, DE
The Clinical Research Assistant is responsible for coordinating, implementing and completing clinical research studies or clinical trials with the Orthogenetics Department at Nemours Children's Hospital Delaware. The job includes but is not limited to: developing protocols, recruiting patients, assisting in budget and documents preparation, in-servicing research teams, recruiting patients, obtaining patient consents, educating patients, conducting study procedures, collecting data, keeping records, performing analysis, and assisting in manuscript / abstract preparation.
A high level of organization with attention to detail and the ability to manage multiple responsibilities is required. This position will work with multiple departments and must maintain a high level of professionalism and a continuous process improvement mindset.
The Clinical Research Assistant will be required to complete Human Subjects Protection (HSP) training and CITI training (including Good Clinical Practice (GCP).
Required skills include ability to work with children, experience with computer data entry, good verbal and written communication, and skills with Microsoft WORD, EXCEL and ADOBE.
Essential Functions:
Follows all aspects of Good Clinical Practices in the conduct of clinical research; assists in identifying, reporting, and following up on Serious Adverse Events.
Assists in protocol preparation; assists in budget development; prepares documents as required by sponsoring agencies; develops source documents; develops consent and assent documents; prepares IRB memoranda.
Attends investigator meetings, as assigned; interacts with representatives of sponsoring agencies.
In-services staff for study purposes.
Recruits patients.
Develops strategies to assure study subject compliance with protocol requirements.
Coordinates protocol activities; prepares clinical specimens for shipment to central laboratories.
Performs clinical data gathering and measurements.
Maintains study medication accountability records; maintains databases; assists in data analysis and manuscript / abstract preparation.
Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
Assists with stipend requests for patients.
Additional miscellaneous duties and responsibilities, as may be assigned from time to time by management.
Qualifications:
At least 1 year clinical research experience
Associate Degree is required (or in lieu of associate degree, two years of clinical research experience is required)
Effectively uses Microsoft computer software
Demonstrates ability to coordinate and establish priorities among diverse tasks
Effectively communicates verbally and in writing
Auto-ApplyClinical Territory Associate
Clinical research associate job in Wilmington, DE
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, lets advance the world of minimally invasive care.
Job Description
*Please note: Candidates must live within or be willing to relocate to the Wilmington, DE Area to perform the duties of this role.
Primary Function of Position
The
Clinical Territory Associate
(CTA) is a 24+ month developmental role that will partner with the Rehoboth Beach, DE team to gain knowledge in all aspects of our business to include technical, clinical, and sales.
Essential Job Duties
(Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)
Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management
Guides technical in-services for customers to include OR staff, surgeons, etc.
Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas
Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position
Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports
Qualifications
Required Skills and Experience
(Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job)
Minimum 1-year leadership (military) experience or 1 year of outside sales experience required
Ability to travel up to 25%, and work nights and weekends as needed
Required Education and Training
(As applicable - Specific education and training that an individual must possess in order to successfully perform in job)
Bachelor's degree required
Working Conditions
(As applicable - Any physical requirements for the job. If not applicable, state “none”)
None
Preferred Skills and Experience
(As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)
Proven record of success
Ambition and exceptional work ethic
Ability to excel in a high-energy, fast-paced environment
Excellent interpersonal skills and persuasive communication skills
Proven ability to work effectively as part of a team
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Mandatory Notices
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay + commission, benefits, and equity. The on target earnings for this position are listed.
Sr Director Clinical Research Scientist IAI
Clinical research associate job in Wilmington, DE
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary The clinical scientist will provide scientific, clinical, and operational input to early and late stage clinical development programs.
This role will work on cross-functional study teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication.
Key Responsibilities Development of protocols for clinical studies.
Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
Monitor, review and summarize safety and efficacy data in ongoing studies.
Represent clinical development on project teams.
Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies.
Serve as liaison to project teams, CRO's, Clinical sub-teams, and others.
Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest.
Qualifications Degree in scientific/life-sciences field.
Pharm.
D.
or Ph.
D.
preferred.
Minimum of 5 years of drug development experience are required.
Alternative drug development experience will be considered.
Prior Dermatology or immunology experience is preferred.
Ability to work independently, multi-task, and work in a fast-paced environment.
Excellent written and oral communication skills.
Strong Analytical ability.
Ability to accommodate up to 20% travel or as business dictates Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.
Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.
You can learn more about this process here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
Clinical Research Assistant
Clinical research associate job in Wilmington, DE
The Clinical Research Assistant is responsible for coordinating, implementing and completing clinical research studies or clinical trials with the Orthogenetics Department at Nemours Children's Hospital Delaware. The job includes but is not limited to: developing protocols, recruiting patients, assisting in budget and documents preparation, in-servicing research teams, recruiting patients, obtaining patient consents, educating patients, conducting study procedures, collecting data, keeping records, performing analysis, and assisting in manuscript / abstract preparation.
A high level of organization with attention to detail and the ability to manage multiple responsibilities is required. This position will work with multiple departments and must maintain a high level of professionalism and a continuous process improvement mindset.
The Clinical Research Assistant will be required to complete Human Subjects Protection (HSP) training and CITI training (including Good Clinical Practice (GCP).
Required skills include ability to work with children, experience with computer data entry, good verbal and written communication, and skills with Microsoft WORD, EXCEL and ADOBE.
Essential Functions:
* Follows all aspects of Good Clinical Practices in the conduct of clinical research; assists in identifying, reporting, and following up on Serious Adverse Events.
* Assists in protocol preparation; assists in budget development; prepares documents as required by sponsoring agencies; develops source documents; develops consent and assent documents; prepares IRB memoranda.
* Attends investigator meetings, as assigned; interacts with representatives of sponsoring agencies.
* In-services staff for study purposes.
* Recruits patients.
* Develops strategies to assure study subject compliance with protocol requirements.
* Coordinates protocol activities; prepares clinical specimens for shipment to central laboratories.
* Performs clinical data gathering and measurements.
* Maintains study medication accountability records; maintains databases; assists in data analysis and manuscript / abstract preparation.
* Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
* Assists with stipend requests for patients.
* Additional miscellaneous duties and responsibilities, as may be assigned from time to time by management.
Qualifications:
* At least 1 year clinical research experience
* Associate Degree is required (or in lieu of associate degree, two years of clinical research experience is required)
* Effectively uses Microsoft computer software
* Demonstrates ability to coordinate and establish priorities among diverse tasks
* Effectively communicates verbally and in writing
Auto-ApplySpecialist, Clinical Business Operations, Oncology
Clinical research associate job in Dover, DE
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA).
+ Assist with the entry of Contractual Agreements into an electronic document repository.
+ Ensure all outsourcing decisions are properly documented, compliant, and audit-ready.
+ Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate.
+ Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements.
+ Perform other duties as requested.
**Key Core Competencies**
+ Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities
+ Ability to proactively identify and act on opportunities for operational efficiencies
+ Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude
+ Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution
+ Excellent written and oral communication skills
**Education and Experience**
+ BA/BS preferred with at least 2 years experience, or 5 years equivalent experience
+ Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Senior/Executive Director, Clinical Research Scientist
Clinical research associate job in Wilmington, DE
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function) This position is responsible for working with the physicians within Clinical Development to co-lead and provide clinical research support for programs as assigned by phase or therapeutic area.
Essential Functions of the Job (Key responsibilities) Design and author protocols for clinical studies Responsible for providing clinical input into eCRF design, SAP, and TLFs.
Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends.
Provide clinical updates on assigned compounds/programs to Sr.
management, Project Teams, Joint Project Teams and/or Steering Committees (if appropriate), Clinical sub-teams, internal strategy and governance meetings, eDMC meetings, steering committees, advocacy groups, scientific advisory boards, and publications committees Lead or co-lead the ICF risk language across a compound to ensure a consistent approach Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans Maintain alignment with the asset Global Lead, Operational Asset Lead, and Global Product Strategy Lead Lead, co-lead, and contribute to the review of clinical sections of documents such as IND, IND amendments, Investigator Brochures, oncology unique CRFs, Annual Reports and other Health Authority submissions Manage relevant issue escalation to resolution, as items arise on Clinical Development Programs Coordinate, lead, and provide clinical input on internal and external slide presentations to ensure consistency of content Attend and present at various meetings with internal and external stakeholders (eg, investigator meetings, scientific advisory boards, etc) Develop relationships with appropriate consultants and External Experts and utilize these relationships to obtain feedback on protocol design and compound strategy Clinical lead for abstracts, posters, oral presentations, and manuscripts for assigned compounds Contribute or lead process improvement initiatives Provide mentoring, leadership, guidance, and clinical science expertise to Incyte personnel to enable proper decision-making Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest Liaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as needed Liaise with key translational medicine leadership on strengthening and implementing a biomarker plan from a clinical point in development studies for a consistent approach as applicable Consult when/if asked by Finances and Clinical Operations on the program budget and at times contribute as needed to the planning of trial/program budgets Qualifications (Minimal acceptable level of education, work experience, and competency) Degree in scientific/life-sciences field such as Master's, Pharm.
D, or Ph.
D/EdD degree preferred or equivalent experience Minimum of 10 years of experience in research with at least 6 years of drug development experience are required.
Alternative drug development experience will be considered.
Prior Oncology Drug Development experience required Global oncology trial experience and Health Authority experience are highly preferred Excellent written and verbal communication skills Strong analytical and strategic ability Ability to work independently and to multi-task large projects or compounds, ability to change pace and tasks as needed, and to work in a dynamic environment Knowledge of good clinical practice, FDA and EMEA/CHMP regulations, and guidelines Experience in managing team members is a plus.
Ability to lead and/or be a proven leader in a line function responsibility, as well as having an ability to influence in a matrix global environment Have proven ability to drive decisions and manage in challenging business situations Ability to accommodate up to 20% travel or as business dictates Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.
Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.
You can learn more about this process here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
Lead Clinic Classroom Coordinator
Clinical research associate job in Newark, DE
Are you ready to be the driving force behind a thriving, creative environment where future beauty leaders blossom? Paul Mitchell The School - Delaware is searching for a dynamic, passionate, and motivated Lead Clinic Classroom Coordinator to join our team full-time. If you're excited about leading with purpose, inspiring others, and creating memorable guest experiences, we want to hear from you! Take the next step in your career and apply today.
Pay: We offer our Lead Clinic Classroom Coordinator a competitive pay starting at $19 per hour, depending on experience.
Benefits:
Health
Dental
Vision
Sick time
Vacation time
Discounts on professional products and services
Holiday bonuses
WHAT SETS US APART
Nestled in the heart of the state on Route 40 in Newark, our vibrant cosmetology school draws aspiring beauty professionals from Delaware, Maryland, New Jersey, and Pennsylvania. At Paul Mitchell The School Delaware, we're all about empowering dreams and unlocking potential through our hands-on cosmetology, esthetics, and instructor programs. We believe in cultivating a supportive and inspiring environment, not only for our students but also for the broader community. Whether you're starting your beauty career or looking to enhance your skills, Paul Mitchell The School Delaware is where your journey begins. Join us and be part of a place where education goes hand-in-hand with passion, creativity, and community!
REQUIREMENTS FOR SUCCESS AS OUR LEAD CLINIC CLASSROOM COORDINATOR
We are looking for someone who can meet the following qualifications:
Sales and service experience
Excellent leadership skills
Strong communication and organization skills
Tech-savvy with basic computer and phone skills
Passion for beauty, education, and making people feel their best
Do you have what it takes? Keep reading to see if you'd love this role as our Lead Clinic Classroom Coordinator!
YOUR NEW ROLE AS OUR LEAD CLINIC CLASSROOM COORDINATOR
This is a full-time position working 40 hours per week, with some evenings and weekends required to accommodate our students and guests.
As our Lead Clinic Classroom Coordinator, you'll be the heartbeat of our clinic classroom. You'll welcome guests with warmth and professionalism, lead the Experience Desk team, and ensure smooth service flow. You'll coach Future Professionals, celebrate their wins, and drive service and retail goals. Every day, you'll help create a polished, high-energy environment that reflects the Paul Mitchell brand - and you'll love every minute of it.
Are you ready to take the next step in your career? Join a team that's shaping the future of the beauty industry. Our initial application process is quick, easy, and mobile-friendly! Apply now!