Project Lead, Clinical Data Management
Samumed is a pharmaceutical platform company based in San Diego, California, focused on advancing regenerative medicine and oncology applications through research and innovation (www.samumed.com).
Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the company to develop small molecule drugs that have the potential to address numerous degenerative conditions as well as many forms of cancer. Samumed is currently conducting clinical trials for multiple disease areas, including oncology, osteoarthritis, Alzheimer’s disease, androgenetic alopecia, psoriasis, and idiopathic pulmonary fibrosis, and it has a broad pipeline targeting areas of significant unmet medical need.
Job Description and Responsibilities:
We are seeking a responsible, dynamic, creative and highly motivated Project Lead to join our Clinical Data Management (CDM) team to help develop standards to increase efficiencies, implement process improvements, collaborate with cross-functional teams, and participate in the conduct of data management activities across all phases clinical trials. This is a full-time position in the company’s San Diego headquarters. Specific responsibilities of the position include:
- Working in tandem with the CDM team to develop a standardization of design, documentation, testing, and implementation of clinical data collection (i.e., CRF standards), and clinical database review
- Translating clinical protocols to database specifications that serve to ease site burden on entering data, as well as ensuring all necessary information for analysis is captured accurately
- Overseeing database development, both in-house as well as when contracted with a CRO
- Providing creative and innovative strategies to data collection and standardization with both short-term and long-term departmental vision
- Serving as departmental contact for vendor relations, reconciliation and transfer processes
- Working with the CDM team to create departmental SOPs that govern vendor relationships, clinical database development and data upkeep
- Proactively identifying risks to timelines and data integrity and manages appropriately
- Creating and applying standards in data cleaning, trend analysis and coordination of cross functional participation in data review
- College degree(s) in Life Sciences, Computer Science or Business preferred
- 4-6 years of relevant clinical data management experience in a Pharmaceutical, Biotech or CRO environment
- Strong GCP and regulatory knowledge including FDA and ICH regulations
- Advanced ability to define problems, collect data, establish facts, and draw valid conclusions
- Ability to manage vendor relationships
- A flexible attitude with respect to work assignments and continued industry related education
- Must have ability to innovate, think strategically and conceptually, and manage multiple projects simultaneously
- Ability to handle even difficult situations professionally and maintain a professional and caring demeanor
- Proven ability to collaborate in a team environment and work independently
- Excellent oral and written communication skills
- Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
TO APPLY, PLEASE EMAIL RESUME.
NO phone calls please.