The Clinical Data Manager is responsible for the oversight and management of all clinical data management activities from study start-up through database lock for multiple clinical studies. The Clinical Data Manager will interact well with the RefleXion Clinical Affairs team and collaborate effectively with RefleXion staff, vendors, clinical research coordinators, and principal investigators to ensure clinical data management activities meet or exceed the expectations for timelines and quality standards.
The Clinical Data Manager will have demonstrated experience in managing clinical study data, exceptional organizational skills and will be comfortable working in a fast-paced environment.
- Performs Clinical Data Management tasks from study start-up through database lock for clinical studies.
- Manages study data management schedule and ensure completion of data management deliverables per study timelines.
- Develop and maintain study-specific data management documentation and procedures including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Edit Check Specifications, Coding Guidelines, Change Control Documentation, Database Audit and Lock Procedures.
- Develops and/or oversees the development of clinical study database by the EDC/CRO vendor.
- Perform and/or participate in User Acceptance Testing (UAT).
- Reviews data listings and issues queries.
- Leads and/or participates in database clean-up and database lock activities.
- Maintains effective working relationships with internal study team, study site personnel, and vendors including CROs, core labs, consultants.
- Collaborates with Biostatisticians, Safety representatives, and other team members as required.
- Organizes and files applicable clinical study documents per Study Master File Index (SMFI).
- Other duties as assigned.
- Bachelor’s degree.
- 5+ years of Clinical Data Manager experience required.
- Proficiency with multiple electronic data capture systems required.
- Experience in medical device and oncology studies is highly desirable.
- Willing to travel up to 20%.
Company Benefits and Perks – What you will love about us!
All positions at RefleXion are eligible to receive the same benefits, listed here. We also want to highlight the following perks that add to our collaborative and team-work company culture. As we continue to grow as a company, we strive to have these benefits and perks grow with us – we are so excited for what is in store!
- The opportunity to work with a passionate, driven team in a pre-IPO start-up environment
- Competitive compensation and stock option package
- Three (3) weeks PTO to start
- Medical (both HMO and PPO options), Dental and Vision
- Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
- Employee Assistance Program (EAP)
- Employer paid Life Insurance
- RefleXion Benefit Hub – for company exclusive discounts and deals on a variety of sites and items
- Free daily on-site lunches
- Kitchens filled with a variety of healthy and delicious snacks and drinks – including espresso and soda machines!
- Company culture building events such as Coffee Chats with the Executives, Friday Afternoon Ice Cream Socials and monthly Book Club
- On-site mobile car wash services weekly
- Electric car charging stations on site