The Senior Manager, Clinical Data Management (Sr. Mgr., CDM) is responsible for data management activities across one or more studies from study start-up through study closure to ensure completion per established project team goals and objectives. The Sr. Mgr., CDM will report to the Head of Clinical Data Management and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical data are complete, high quality, and delivered on time and to budget.

This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).

Responsibilities

• Independently leads EDC development, including CRF development, EDC specification process, edit check development and User Acceptance Testing including test scripts and execution logs, issue logs, and UAT summary reports.
• Reviews and assists in the development of study documents drafted by CROs such as data transfer agreements, eCRF Completion Guidelines, and Data Management Plans.
• Ensures the quality of clinical data within the EDC and other databases through data review and data reconciliation processes and communicates any outstanding issues.
• Develops, in collaboration with the CRO, a clean patient tracker.
• Coordinates transfers of SAS datasets or electronic data transfers from CROs.
• Leads database lock process.
• Monitors and tracks the quality of all data management deliverables ensuring audit practices have been enacted to validate the quality and assurance of database content and supporting documents.
• Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practice.
• Effectively oversees contracted vendors, or vendor groups within CRO, to ensure data are complete, accurate and delivered within agreed on timelines.
• Independently serve as the lead point of contact for all data management study-related communications.
• Actively participates in team meetings and presents Data Management concerns risks and issues.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.

• Bachelor’s degree or equivalent in life science, computer science, or related discipline with 8 years’ experience.
• Minimum 5+ years of experience working within a pharmaceutical or CRO environment, with experience in managing Phase I, II or III studies, from start-up through closure.
• Demonstrated proficiency in various EDC Systems within the last 3 years.
• Demonstrated proficiency in the data management processes.
• Experience in managing external EDC vendors for Data Management.
• Understanding of Clinical Data Interchange Standards Consortium (CDISC), CDASH, and SAS® terminology.
• Understanding of the coding process and terms in MedDRA, WHODRUG and CTCAE.
• Thorough knowledge of applicable regulatory rules and guidelines.
• Excellent organizational skills and attention to detail.
• Effective communication and interpersonal skills.
• Able to set priorities and juggle multiple projects and demands.
• Able to think critically and independently and be a proactive problem-solver.
• Able to lead and work independently while exercising initiative, flexibility, and sound judgment.
• Comfortable working with different levels of the company including senior level management.
• Demonstrated proficiency in Microsoft Word, Project, PowerPoint, Office, and Excel.
• Ability to operate in alignment with Pliant’s values.

The annual base salary for this role is $170K – $180K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.