Job Title : Sr Clinical Scientist
Job Location : Raleigh NC
Contract : 06 Months to Hire
Job Description:
Accountable for contributing scientific expertise to the trial design phase of clinical projects under development
- Provide scientific and strategic input across various stages of clinical development to achieve market approval for new products and/or novel indications.
- a. Duties performed as a member of a cross-functional team of internal and external experts and in support of the clinical director.
- b. Projects are focused on medical devices, drugs, biologics, and/or other products for human use.
- c. Projects may span from in-development to post-marketing studies and products.
- Coordinate and integrate data and information from a variety of sources (e.g., internal and external studies, research documentation, and published literature) to support various clinical development initiatives.
- Consolidate input from internal and external contributors to develop appropriate key messaging.
- Support early-phase development activities, including curation, review, and interpretation of preclinical, exploratory data.
- Provide scientific guidance and technical expertise within teams, across departments, and across functions by providing strategic, actionable direction, creating a strong sense of team unity and identity, and providing positive, constructive feedback.
- Identify and troubleshoot study-specific issues, competing priorities, and clinical or scientific challenges.
- Ensure effective, accurate, and timely communication of key issues and progress to the team and senior management.
- Support planning and preparation for internal and external stakeholder meetings (e.g., workshops/summits, investigator meetings, scientific advisory boards, and regulatory meetings)
Accountable for contributing scientific expertise to the trial design phase of clinical projects under development
- Write, review, edit, and approve high-quality and timely clinical documents, contributing scientific/technical expertise related to clinical development and document preparation.
- Demonstrate understanding and interpretation of data generated from a variety of sources, including clinical study data and study results (i.e., tables, figures, and listings) and peer-reviewed literature and provide meaningful scientific interpretation and feedback to team members and other stakeholders.
- Communicate with and work effectively and productively with multidisciplinary, international teams while executing project plans.
- Ensure documents comply with current local and international regulations, laws, scientific and regulatory guidance, Good Clinical Practice, and internal policies and procedures.
- Proactively identify risks and escalate current/active/future issues; propose and enact solutions, developing contingency plans as needed.
- Ensure the successful execution and presentation of critical documents to leadership.
Accountable for contributing scientific expertise to the trial set-up and execution phases of clinical projects, including results interpretation and reporting
- Support, as a member of a cross-functional team the selection of relevant COAs
- Support and provide scientific input for activities related to the development/validation of project specific COAs
Accountable for contributing scientific expertise to regulatory activities
- Provide scientific input for clinical parts of key regulatory and project documents (e.g., Clinical Evaluation Plan (CEP) and Report (CER), Instructions for Use, and Post-Market Clinical Follow-up Plan (PMCFP) and Report (PMCFR).
- Provide scientific input for appropriate disclosure of clinical trial data in public registries.
Accountable for contributing scientific expertise to the presentation and publication of clinical trial results
- Prepare and present trial data, to internal and external stakeholders, using clear, concise, and consistent result summaries.
- Provide scientific and written expertise for manuscripts, abstracts, and poster submissions in collaboration with R&D, Medical Affairs, and Commercial colleagues.
- Demonstrate knowledge of Good Publication Practices and editorial policies and apply expertise to publishing projects
Accountable for providing oversight of external medical writing vendors
- Effectively manage assigned writing projects, including projects outsourced to vendors.
- Oversee and review work of external writers to ensure Client Sops are followed, correct templates are used, and quality is maintained.
