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Become A Senior Clinical Research Scientist

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Working As A Senior Clinical Research Scientist

  • Getting Information
  • Analyzing Data or Information
  • Identifying Objects, Actions, and Events
  • Updating and Using Relevant Knowledge
  • Documenting/Recording Information
  • Mostly Sitting

  • $82,240

    Average Salary

What Does A Senior Clinical Research Scientist Do At Fresenius Medical Care North America

* A seasoned, experienced professional with a full understanding of how clinical trials are conducted.
* Support all operational aspects of clinical trial activities (Phase I through IV) and clinical program activities as assigned.
* Responsibilities include:
* Development of clinical trial protocols based on the study design and related documents
* Development of study tools including guidelines and training materials for study sites and investigators
* Communication with CROs as well as clinical and analytical laboratories
* Implementation of issue resolution plans
* Contact with study coordinators at trial sites; tracking of local study approvals (IRB reviews) and patient enrollment
* Ensuring study drug supply
* Development of Clinical Study Reports
* Contribute to the development of SOPs and department policies and procedures
* Should be able to lead clinical studies as a Clinical Trial Lead and assume responsibility of the assigned study
* Author a protocol and develop relevant study related documents.
* Responsible for the overall conduct of a study/studies and related activities
* Must be able to work and manage multiples studies simultaneously
* Must be able to develop study budget and timelines.
* Ensure that all trial deliverables are met according to timelines, budget, operational procedures and quality standards
* Support and Coordinate Investigator initiated studies (IIRS)
* Responsible for reviewing various proposals from investigators
* Scheduling and coordinating the Review Committee meetings
* Keeping track of study proposals and related documents
* Support clinical outsourcing specifications and day to day operational activities with Contract Research Organization(s) (CROs) and/or other 3rd parties.
* Contribute to the selection of external vendors by reviewing their scope of work, budget and timelines
* Manage interactions with other relevant functions including Regulatory Affairs, Drug Supply Management, MSL team, Clinical monitoring (CRA team), Contract and Legal department, as well as external partners
* Update regularly all trial information in database and track accuracy of information
* Contribute to the ongoing scientific review of the clinical trial data during the course of the trial
* Support trial data analysis and reporting (e.g., SAEs)
* Assist Clinical Research and Development in identifying potential investigators and sites for clinical trial
* Provides training, mentoring and guidance to less experienced Clinical Research Scientists
* Should be a team player and be able to work with study team members effectively
* Mentor other staff as applicable.
* May escalate issues to supervisor/manager for resolution, as deemed necessary.
* Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
* Assist with various projects as assigned by a direct supervisor.
* Other duties as assigned.
* Additional responsibilities may include focus on one or more departments or locations.
* See applicable addendum for department or location specific functions

What Does A Senior Clinical Research Scientist Do At Abbott

* Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager.
* Conducts by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff.;
* Creates, manages, or participates in clinical study or clinical evaluation timelines, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines
* Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
* Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
* Writes clinical evaluation plans and reports, study protocols, protocol amendments, informed consents, study reports, risk master lists, and scientific papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
* Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice.
* Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings.
* Participates in and supports audits.
* Interfaces with management on significant matters, often requiring the coordination of activity across organizational units, physicians, and external CROs and medical writers.
* Participates in the development of other technical contributors by supporting training and providing feedback and guidance.
* May participate in a project team.
* Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
* Exercises judgment independently.
* Plans and organizes project assignments of substantial variety and complexity.
* Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives

What Does A Senior Clinical Research Scientist Do At Danaher Corporation

* The Sr Staff Clinical Research Scientist will work closely with the Senior Director of Clinical Affairs to ensure efficient and effective start-up, conduct and close-out of diagnostic clinical trials (such as advanced staining, companion diagnostics or other):
* Clinical evidence strategy – synthesis of Voice of Customer requirements into recommended clinical trial investments.
* These clinical investments are collectively designed to generate clinical evidence (such as a peer-reviewed publication) that meets customer needs and drives market awareness/adoption of a product/technology.
* Study design – diagnostic protocol writing, biospecimen procurement, collaborate on the statistical analysis plan/data management plan, monitoring plan
* Study conduct – management of external vendors & contract research organizations (CROs), quality and integrity of clinical data (data management), clinical study monitoring
* Study reporting – data analysis & presentation to internal and external stakeholders, contribution to clinical reports and peer-reviewed publications
* May provide direction and task oversight to others on the clinical program team for one or more programs
* The role involves collaborations with internal project stakeholders (Clinical Affairs, R&D, Quality, Regulatory, etc.) and external partners (such as co-development collaborators and CROs).
* Qualification
* Demonstrated experience in evidence planning, clinical strategy, study design/execution and study monitoring for clinical diagnostics, medical devices or pharmaceutical products in a regulated environment
* Demonstrated experience in effectively negotiating with regulators (such as the U
* S. Food and Drug Administration) and designing/executing clinical programs resulting in a successful global commercial release
* Experience in oncology, IHC and/or ISH, or pathology imaging are highly preferred.
* Hands-on experience with genomics and/or proteomics assay development is highly preferred
* Able to secure appropriate internal or external technical expertise required and coordinate efforts to resolve compliance or technical issues that may arise during clinical trials.
* Demonstrated strong ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members
* Demonstrated strong ability to handle and resolve conflicts and work under stressful conditions and in an environment of changing priorities
* Demonstrated ability or track record of successful results, building effective teams and getting work done through others
* Demonstrated strong ability to understand complex scientific, engineering and business concepts
* Proven technical writing and presentation skills required
* Demonstrated strong ability to be flexible and resourceful.
* Excellent communication and diplomacy skills required
* Independent, motivated, organized individual with strong analytical and problem solving skills
* Strong computer skills, including demonstrated high proficiency with Microsoft Word, Excel and Powerpoint
* Demonstrated ability to apply the Danaher Business System to track/measure/report performance, solve problems and drive continuous process improvement

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How To Become A Senior Clinical Research Scientist

Medical scientists typically have a Ph.D., usually in biology or a related life science. Some medical scientists get a medical degree instead of a Ph.D., but prefer doing research to practicing as a physician.

Education

Students planning careers as medical scientists typically pursue a bachelor’s degree in biology, chemistry, or a related field. Undergraduate students benefit from taking a broad range of classes, including life sciences, physical sciences, and math. Students also typically take courses that develop communication and writing skills, because they must learn to write grants effectively and publish research findings.

After students have completed their undergraduate studies, they typically enter Ph.D. programs. Dual-degree programs are available that pair a Ph.D. with a range of specialized medical degrees. A few degree programs that are commonly paired with Ph.D. studies are Medical Doctor (M.D.), Doctor of Dental Surgery (D.D.S.), Doctor of Dental Medicine (D.M.D.), and Doctor of Osteopathic Medicine (D.O.). Whereas Ph.D. studies focus on research methods, such as project design and data interpretation, students in dual-degree programs learn both the clinical skills needed to be a physician and the research skills needed to be a scientist.

Graduate programs emphasize both laboratory work and original research. These programs offer prospective medical scientists the opportunity to develop their experiments and, sometimes, to supervise undergraduates. Ph.D. programs culminate in a thesis that the candidate presents before a committee of professors. Students may specialize in a particular field, such as gerontology, neurology, or cancer.

Those who go to medical school spend most of the first 2 years in labs and classrooms, taking courses such as anatomy, biochemistry, physiology, pharmacology, psychology, microbiology, pathology, medical ethics, and medical law. They also learn how to record medical histories, examine patients, and diagnose illnesses. They may be required to participate in residency programs, meeting the same requirements that physicians and surgeons have to fulfill.

Medical scientists often continue their education with postdoctoral work. Postdoctoral work provides additional and more independent lab experience, including experience in specific processes and techniques such as gene splicing, which is transferable to other research projects.

Licenses, Certifications, and Registrations

Medical scientists primarily conduct research and typically do not need licenses or certifications. However, those who administer drugs, gene therapy, or otherwise practice medicine on patients in clinical trials or a private practice need a license to practice as a physician.

Important Qualities

Communication skills. Communication is critical, because medical scientists must be able to explain their conclusions. In addition, medical scientists write grant proposals, because grants often are required to fund their research.

Critical-thinking skills. Medical scientists must use their expertise to determine the best method for solving a specific research question.

Data-analysis skills. Medical scientists use statistical techniques, so that they can properly quantify and analyze health research questions.

Decisionmaking skills. Medical scientists must determine what research questions to ask, how best to investigate the questions, and what data will best answer the questions.

Observation skills. Medical scientists conduct experiments that require precise observation of samples and other health data. Any mistake could lead to inconclusive or misleading results.

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Senior Clinical Research Scientist jobs

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Senior Clinical Research Scientist Typical Career Paths

Senior Clinical Research Scientist Demographics

Gender

  • Female

    47.8%
  • Male

    42.0%
  • Unknown

    10.1%

Ethnicity

  • White

    65.4%
  • Asian

    21.1%
  • Hispanic or Latino

    7.0%
  • Unknown

    5.8%
  • Black or African American

    0.7%
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Languages Spoken

  • Irish

    100.0%

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Real Senior Clinical Research Scientist Salaries

Job Title Company Location Start Date Salary
Senior Clinical Research Scientist Akros Pharma Inc. Princeton, NJ Oct 17, 2016 $160,000
Senior Clinical Research Scientist Purdue Pharma L.P. Stamford, CT May 12, 2012 $124,975
Senior Clinical Research Scientist Cubist Pharmaceuticals, Inc. Lexington, MA Aug 21, 2012 $114,100
Senior Clinical Research Scientist Transmedics, Inc. Andover, MA Jan 01, 2014 $110,000
Senior Clinical Research Scientist Transmedics, Inc. Andover, MA Aug 15, 2011 $100,000
Senior Clinical Research Scientist Avon Products, Inc. Suffern, NY Sep 25, 2010 $87,000

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Top Skills for A Senior Clinical Research Scientist

CROClinicalResearchStudiesRegulatoryDocumentsFDAPhaseIIICrasInvestigatorMeetingsDataManagementPlansCRFClinicalStudyReportsStatisticsGCPSeriousAdverseEventsStudySitesStudyDesignInvestigatorBrochuresIRBDrugSafetyIcfsInd/Nda

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Top Senior Clinical Research Scientist Skills

  1. CRO
  2. Clinical Research Studies
  3. Regulatory Documents
You can check out examples of real life uses of top skills on resumes here:
  • Coordinated all key external and external communications (CRO, Investigator, site study staff, and study team).
  • Support preparation of clinical and regulatory documents and interactions with regulatory agencies such as PDCO, KFDA and DCGI.
  • Support and document clinical animal studies, for both internal purposes and FDA submissions.
  • Assisted with the development and authoring of protocols (Phase III), amendments, Informed Consents.
  • Facilitated the development of Clinical Research Associate (CRAs) Reference Manual.

Top Senior Clinical Research Scientist Employers