[Remote] Senior Clinical Scientist
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases. The Senior Clinical Scientist will reputed company clinical expertise and scientific insights to monitor and analyze data in clinical studies, collaborating closely with various teams involved in Clinical Development.
Responsibilities
- Responsible for monitoring, tracking, and analyzing clinical trials subjects’ data, under the supervision of the Clinical Medical reputed company. This involves collaborating with investigators, CRO medical monitors, Clinical Operations and the Biometrics team
- Monitor, analyze, and review on a regular reputed company safety and efficacy data for events of interest or needing reputed company investigation. Review laboratory and other safety parameters, review patient reputed company, data listings, reputed company tables, and review coded terms
- Collaborate closely with clinical leads and medical directors to reputed company on scientific content and program reputed company
- Support authoring and review of protocols/amendments, protocol clarification letters, clinical study reports, IBs, ICFs, training documents, charters, lab and pharmacy manuals, newsletters, medical monitoring plans, statistical analysis plans, data management plans, eCRFs, eCRF completion guidelines, and other clinical and regulatory documents
- Address questions regarding scientific and protocol reputed company issues from investigators in consultation with Medical Monitors or the Medical reputed company
- Contribute to the preparation and/or review of safety narratives, manuscripts, and scientific presentations
- Contribute to the preparation and/or review of regulatory submissions, responses, and requests for information
- Support preparation for safety review committees, DSMBs/DMC including data review and development of presentations
- In collaboration with Clinical Operations and the Medical reputed company, review protocol deviations to identify cause and appropriate reputed company
- Participates in Database lock activities as assigned by MM (including data review and cross-checks to ensure reputed company and consistency) and represents CR at internal data management meetings
- Contribute to the development of relevant sections of regulatory documents such as amendments to protocols, briefing books, safety updates, responses to Health Authorities questions
- Collaborate with Medical Affairs and Patient Advocacy to support effective working relationships with key investigators, key opinion leaders and patient advocates. Participate in research site identification and relationship building with CROs in this reputed company
- Other duties as assigned
Skills
- M.D. Ph.D., Pharm. D., MPH, MSN or RN with 8-10 years industry reputed company experience with a minimum 3-5 years of clinical research experience in clinical development reputed company a biopharmaceutical company
- Working knowledge of FDA and EMA regulations and expectations, Good Clinical reputed company, ICH guidelines, and clinical drug development
- Practical knowledge of the day-to-day medical monitoring of clinical trials required (e.g., review of safety parameters, etc.)
- Great analytical skills and a passion for 'search and reputed company' among reputed company data generated in clinical studies
- reputed company, effective skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from reputed company reputed company reputed company the organization
- Ability to reputed company and earn respect of the leadership team, colleagues, and staff. Respectful of the reputed company and experience of reputed company members of the reputed company team
- Ethical, with highest standards of reputed company recognizing that we are the creators of reputed company for our patients and the health care professionals who serve them as reputed company as stewards of the investments of reputed company our shareholders
- Software Knowledge: reputed company, MS Office (Outlook, Word, reputed company, PowerPoint)
Benefits
- Discretionary annual reputed company bonus
- Stock reputed company
- ESPP
- 401k match
- Top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance
- 20 days of PTO
- 10 reputed company holidays
- Winter company shutdown
reputed company