Senior Manager Clinical Data Management

Senior Manager, Clinical Data Management

The Senior Manager, Clinical Data Management will collaborate with internal team members and external vendors to manage all aspects of data collection and reporting. The role involves leading the development of systems and procedures to ensure consistency within the Clinical Data Management department.

• Manage and monitor data management activities with CROs or other vendors on assigned studies, building effective relationships with counterparts.
• Review and provide feedback on study documents such as clinical study protocols, protocol deviation plans, medical monitoring plans, statistical analysis plans, mock Tables, Figures and Listings shells, and Clinical Study Reports.
• Approve data management‑related documentation for quality, completeness, and accuracy, including Case Report Forms, Data Validation Specifications, and Data Management Plans.
• Develop and execute procedures for data quality review and data acceptance prior to analyses and database lock.
• Possess knowledge of standard coding dictionaries like MedDRA and WHO drug.
• Represent Clinical Data Management effectively at relevant meetings for all assigned studies and programs.
• Ensure data management deliverables are met within study timelines.
• Manage clinical study budgets, reviewing and approving invoices and identifying out‑of‑scope activities.
• Collaborate with biostatistics, programming, and other functions to meet project deliverables and timelines.
• Monitor in‑house resources and identify potential deficiencies, developing plans to address them.
• Contribute to departmental policy development, standards, and process improvement initiatives.

• Bachelor's Degree in a scientific or health‑related discipline;
  Master's degree is a plus.
• 8+ years of clinical data management experience in a pharmaceutical/biotech setting.
• Experience in managing outsourced clinical data management activities and other vendors.
• Thorough understanding of the drug development process, clinical trial methodology, and regulatory requirements.
• Current knowledge of industry CDM best practices and processes.
• Strong experience with clinical database management systems including EDC, eCOA, and ePRO.
• Effective oral and written communication, project management, and interpersonal skills.
• Proven success in a virtual, global, and multi‑cultural environment.
• Attention to detail and ability to work independently and collaboratively.
• Knowledge of SAS, EDC programming, and systems integration experience.
• Solid understanding of CDASH and CDISC standards.
• Ability to mentor junior staff.

• Strategic, communicative, proactive, and resourceful leadership.
• Experience in end‑to‑end study management.
• Knowledge of ICH guidelines and regulations relating to data management activities.
• Ability to prioritize and manage multiple tasks with conflicting deadlines.
• Proven success in identifying creative solutions to complex study‑related or technical issues.

This position offers flexible part‑time hours, with occasional meetings as early as 6 am PT due to international collaboration with teams in Australia and Basel, Switzerland. The work environment is dynamic and collaborative, emphasizing creativity and teamwork in a global context.

Contract position based out of Foster City, CA.

The pay range for this position is $70.00–$83.00 per hour.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

This position is anticipated to close on Jun 19, 2026.