Company: Innovative Biotechnology Company
Job Title: Senior Manager, Clinical Data Management
Location: San Diego, California
Salary: $126,000 - 164,000 + bonus + RSU
Company Summary:
Our client is an innovative Biotech company who produces allogenic cell therapies for patients with autoimmune diseases and oncology. With an exciting pipeline and a few commercialized products, they have an exceptional level of funding having generated 270million in their series B runway.
They have a fantastic team culture, focusing on the science and improving the lives of cancer patients nationwide.
Due to the success of two compounds, there is now an urgent need to hire and grow out the team. This will be the second hire within the Clinical Data Management sub team.
They are seeking an experienced Senior Manager, Clinical Data Management, who will report directly to the Director of CDM. This role will be responsible for Data Management from study start-up to close-out.
Duties/Responsibilities:
- Review and approve all data management documents, including, case report forms, data management plan, build and validation specifications
- Lead UAT activities
- Ensure the development of project level timelines
- Review and provide feedback to the wider clinical teams on statistical analysis and monitoring plans
- Participate in regular study and project team meetings
- Provide oversight of Data Management and liase with CROs
- EDC System modifications
- Serious Adverse Event (SAE) and third-party data reconciliations
Requirements:
- Minimum 5-8 years of pharmaceutical, biotech or pharmaceutical experience
- Bachelor's degree in science, computer science, or related field preferred
- Successfully managing and overseeing Data Management activities directly or through CRO and providers
- Data Management document knowledge e.g. CRFs, DMP
- Understanding of regulatory guidelines and industry standards e.g. ICH GCP and FDA guidelines, 21 CFR 11
- Extensive knowledge of EDC systems e.g. Medrio
- Knowledge in Oncology or Autoimmune Therapeutic areas are preferred
In addition to a great culture, they offer:
- Highly competitive base salary, plus bonus and RSU, making it one of the best packages on the market
- 401(k) Retirement Plan
- Attractive PTO, including company paid holidays
