Clinical trials specialist job description

The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, helping to deliver projects to the benefit of the patients we serve.

Parexel currently has Home Based Project Leadership opportunities at levels to fit your experience and career goals.
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You will oversee all elements of the trial to ensure project deliverables and client satisfaction are executed to the highest standards. You will actively lead cross functional Parexel and client teams by combining deep clinical research experience with insight into client pressures to develop the right solutions for the clients. Your experience running global clinical trials across all phases will help you achieve operational excellence through on time and on budget delivery to the highest quality. As member of the Project Leadership team, your goal is to exceed client expectations, and help your team achieve success by serving as a role model and coach.

The Global Project Leadership department has dedicated members at all levels who are aligned to work with specific types of clients and deliver solutions customized to fit those client’s needs, working on projects spanning across all phases of global clinical trials, in a wide array of therapeutic areas.
Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with a minimum, 2+ years' experience leading Global Clinical Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director and Project Director.

To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member’s growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills.

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination

#LI-REMOTE

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer. Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

Would you like to take part in developing new therapies that really make a difference in patients' lives? Do you desire both autonomy and collaboration in taking on scientific challenges that interest you? Are you interested in joining a talented team where everyone has a voice?

The Sr. Clinical Trial Specialist (Sr. CTS), works closely with the Clinical Operations team to support clinical trial execution. Key accountabilities include the coordination of activities associated with the start-up and management of a clinical trial in compliance with SOPs, regulations, and ICH/GCP guidelines. The Sr. CTS interacts with the program and study trial managers, Director of Clinical Operations, Regulatory, and other key functions both internally and externally to support activities and project deliverables within the required time frame and budget.

During your first year, your goals will include:Complete clinical trial tasks and efficiently for assigned studies Assist with oversight of clinical study by tracking CRO and third-party vendors' activities Manage vendor(s) with supervision Coordinate investigator site contract and budget review Collaborate with study team to develop clinical trial documents, including informed consent forms, monitoring plans, protocols and amendments, trial logs, site tools, and other documents, as required Assist with budget oversight by tracking site payments and vendor invoices in collaboration with finance and study team Support clinical trial managers with study execution, according to good clinical practices (GCP) and standard operating procedures (SOPs). May coordinate activities with Clinical Research Organization (CRO), study vendors, and clinical sites Provide general logistical and administrative support for clinical trials, such as creating agendas and taking minutes at meetings, preparing for investigator meetings, and assisting with purchasing and work orders

We'd love to hear from you if:You take pride in being highly organized and have strong attention to detail You thrive in an environment where we work independently and on teams Your academic background includes a Bachelor's Degree, preferably in a health or science field You have at least 4+ years of experience in clinical operations and study management within a life sciences company or at a CRO. Study Coordinator experience will be considered.You have experience with the study start-up process, global Phase I and II clinical trials - particularly Neuroscience, Oncology, orphan diseases and/or Immunology trials, and various clinical trial management systems (desirable) Basic knowledge of ICH/GCP and FDA regulations Occasional travel may be needed You have a point of view but are low ego
#LI-FS1

Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.

Alector was named on Fortune's "Best Workplaces in Biopharma" top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022.

Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other's assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

The Clinical Trial Support Specialist (CTSS) will work as part of the Clinical Study Team, to conduct and facilitate the smooth running of Adaptimmune clinical trials from study start up through to study close out, in accordance with relevant regulations, SOPs, and study specific procedures; will be responsible for assisting the Clinical Scientist with the day to day coordination and administration activities required in the running of Adaptimmune clinical trials.

CTSS activities will include but are not limited to preparation of site submission start up packages, interaction with sites to ensure all required documents are in place for site activation, filing of study documents in the study Trial Master File and coordinate and prepare study documentation including ICFs, Study Manuals etc.
Key Responsibilities

Study Start up

* Support EU/US site pre-qualification
* Assign site and PI numbers
* Review and validate site identification list
* Follow up with site on ethics submission and approval received (initial submission and amendments)
* Review feedback/comments from sites on the ICF to ensure compliance with ADAP requirements; resolve changes requested by the site and approve with support from Clinical Team, safety and legal.
* Prepare, collect and negotiate Confidentially Agreements (CDA) as required. Resolve CSA changes requested by the site and approve any change in CSA language with support from Clinical Team and Legal; Collect internal CSA signatures
* Interface with internal TMF group to ensure site submission package is sent and start up documents are submitted to TMF
* Work with Contract Research Organization (CRO) to ensure study start up activities are completed within agreed timelines

Study Conduct

* Manage SAE email distribution
* Ensure good understanding of project scope, milestones, budgets to confirm payment of invoices
* Submit relevant documents to the Trial Master File
* Create and maintain Study Procedures Manual and ICF as needed
* General Clinical Operations Support
* Liaise with other internal departments to avoid duplication of effort across studies around completion of forms (eg, IBC forms), vendor form updates, etc.
* Manage the SNAP (subject number assignment program) across studies; Maintain relevant SOP
* Proactively keep clinical scientists and manager informed about work progress and any issues (including conflicting priorities and free capacity)
* Maintain a good working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Adaptimmune SOPs, other Adaptimmune training requirements, and study specific procedures and training
* Escalate any issues that require immediate action to the clinical scientist
* Proactively work with team members to meet project goals
* Support metric tracking and protocol deviation quarterly review
* Work with CROs and vendors to ensure the smooth operation of ongoing study activities

Qualifications & Experience

* Bachelor's degree (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience
* 3-5 years of clinical research experience

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.