Sr. Manager Clinical Data Management

Sr. Manager, Clinical Data Management POSTION SUMMARY The Sr. Manager, Clinical Data Management will collaborate primarily with internal team members and external vendors to manage all data collection and data reporting aspects. In addition, the Sr. Manager will lead the development of systems and procedures to assure consistency across the Clinical Data Management department. Overall responsibilities will include supporting clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals in accordance with Standard Operating Procedures (SOPs) and regulatory directives. Participate in staff recruitment, onboarding, training and mentoring. PRIMARY RESPONSIBILITIES · Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies, build effective relationships with CRO/vendor counterparts · Able to review and provide feedback to the multi-disciplinary team on other study documents e.g. clinical study protocols, protocol deviation plans, medical monitoring plan, statistical analysis plan, mock Tables, Figures and Listings (TFL) shells and Clinical Study Reports (CSRs) · Reviews and approves DM related documentation for quality, completeness, and accuracy; including but not limited to Case Report Forms, Data Validation Specifications, Case Report Form Completion Guidelines, Data Management Plans, Data Transfer Agreements, Medical Coding Guidelines, Validation Plan, User Acceptance Testing (UAT) documentation, Data Review Plan, etc. · Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting · Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock · Knowledge of standard coding dictionaries MedDRA, WHOdrug, etc., and related best practices · Attends and represents CDM effectively on all assigned studies and programs at relevant meetings. · Understand critical tasks and milestones; ensure data management deliverables are met per study timelines · Manage the clinical study budget, ensuring the project remains within scope through reviewing and approving invoices, identifying out-of-scope activities and its appropriate handling · Work collaboratively with biostatistics, programming and other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting · Monitor in-house resources of assigned projects and identify potential deficiencies; work with supervisor to develop and implement a plan to overcome any obstacles · Contribute to developing and implementing departmental policies, standards and process improvement initiatives as needed · Support implementation of data standards · Align with and support management and corporate goals or objectives · Contribute to activities supporting audits & inspection readiness and regulatory inspections · Assist in selecting vendors/CROs e.g. reviewing RFIs/RFPs and participating in bid defenses · Identify, manage, mentor and develop Clinical Data Management team members · Good working knowledge of medical/scientific terminology and knowledge of ICH guidelines and regulations relating to data management activities QUALIFICATIONS Education/Experience · Bachelor’s Degree preferably 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 Knowledge, Skills and Abilities · Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives · Experience in managing outsourced clinical data management activities and/or other vendors · Thorough understanding of the drug development process, clinical trial methodology, regulatory requirements, ICH, GCP and GCDMP · Current and extensive knowledge of industry CDM best practices and processes · Strong experience with various clinical database management systems including EDC, eCOA, and ePRO · Strong and effective oral and written communication, project management, and interpersonal skills · Proven success working in a virtual, global and multi-cultural environment · Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors · Proven success in identifying creative solutions to complex study-related or technical issues · Knowledge of SAS, EDC programming, systems integration experience · Solid understanding of CDASH and CDISC standards · Ability to mentor junior staff Job Type & Location This is a Contract position based out of Foster City, CA. Pay and Benefits The pay range for this position is $70.00 - $83.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • 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) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Jun 19, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. 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. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options. San Francisco Fair Chance Ordinance: 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. Massachusetts Lie Detector: 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. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.