Manager/ Senior Manager, Clinical Data ManagementJob DescriptionThe Manager/ Senior Manager of Clinical Data Management will provide support for Clinical Studies and provide oversight of DM CROs. This role is crucial in ensuring that contracted activities are completed by vendors according to specified quality standards and timelines. The position involves coordinating ongoing data management activities with vendors to support the execution of clinical trials, drug development processes, and global submissions through to approval.Responsibilities
Provide independent project-level oversight of clinical data management activities, monitoring and reporting on overall study progress.
Perform Clinical Data Management responsibilities on all assigned studies.
Collect requirements for data visualization tools to support development of DM operational standards and test requirements.
Oversee Data Management vendors at the portfolio level by developing, managing, and reviewing metrics to identify and resolve database or operational issues.
Manage and facilitate relationship and escalation meetings to maintain expected performance and propose resolutions for poor performance.
Develop, draft, and finalize Data Management systems, templates, processes, and responsibilities across the department for operational standardization.
Monitor quality of data deliverables from external vendor sources for all assigned studies, focusing on assessing and producing metrics on overall database trends.
Develop and oversee Data Management specific documentation including but not limited to the specifications, completion guidelines, edit check specifications, validation documents, DMP, and DRP.
Oversee activities of applicable Data Management study vendors and CRO Data Management counterparts to ensure adherence to scope of work and service agreements.
Ensure deliverables are met in accordance with study milestones/timelines and expected data quality and budget.
Oversee contracts, budgets, and accruals to ensure timely maintenance and avoid study timeline delays.
Perform required User Acceptance Testing and development testing of the database technology prior to deployment.
Participate in internal study team meetings and teleconferences with outside vendors and study personnel.
Essential Skills
Bachelor’s Degree
Experienced and tenured Senior Clinical Data Manager, ideally with sponsor experience
Excellent interpersonal, communication, and organizational skills
Ability to manage multiple programs and processes simultaneously in a fast-paced, team-based environment
Familiarity with Medidata RAVE, data visualization tools, and CDISC data standards
Strong understanding of standard GCP practices for clinical trials
Expertise in visualization tools/data lakes (e.g., Spotfire, Tableau, JMP)
Collaborative and able to motivate and energize cross-functional team members
Expertise in vendor management from selection through ongoing relationship management
Proven ability to build relationships and manage expectations with CROs/external vendors
Strong problem-solving and analytical skills
Working knowledge of FDA & ICH/GCP regulations and guidelines
Strong knowledge of CDISC (CDASH/SDTM), medical dictionary coding standards, FDA and ICH guidelines, GCP, 21 CFR Part 11, and Good Clinical Data Management Practices (GCDMP)
Experience with documentation related to CDM
Hands-on experience in overseeing vendors and acting as a lead on multiple studies or compounds
Familiarity with data visualization tools
Ability to facilitate discussions among groups with diverse technical expertise and progress decisions on complex topics
Pay and BenefitsThe pay range for this position is $70.00 - $85.00/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 TypeThis is a fully remote position.Application DeadlineThis position is anticipated to close on Mar 12, 2025.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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
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] (%[email protected]) for other accommodation options.