Associate Project Lead / Project Lead, Clinical Data Management

San Diego, CA

  • We are seeking a responsible, dynamic, creative and highly motivated Associate Project Lead or 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.
  • The specific title will be dependent upon experience. 
  • This is a full-time position in the company’s San Diego headquarters. 

Specific Responsibilities

  • Working in tandem with the CDM team and cross-functional team members to develop a standardization of design, documentation, testing, implementation of clinical data collection (i.e., CRF standards), training, 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
  • Managing database development, maintenance, and lock, 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
  • Assisting in managing the workload of supportive data management team members to most efficiently resource time and tasks

Requirements

  • College degree(s) in Life Sciences, Computer Science, Business, or similar Bachelor degree or higher preferred
  • 2-6 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. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded.