Project Lead, Clinical Data Management

San Diego, CA

  • Samumed is 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 of clinical trials.
  • This is a full-time position in the company’s San Diego headquarters. 

Specific Responsibilities

  • 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

Requirements

  • 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

Please submit your resume or additional inquiries to apply@samumed.com