Clinical Document Management Team Lead (Director)
As the Clinical Document Management Team Lead (Director), you will be responsible for the strategic direction of clinical document management for Takeda to ensure compliance with regulatory legislation and Takeda policy and procedures which are innovative and continuously assessed for efficiency and effectiveness.
You will lead the Clinical Document Management Team (CDM). Determining long range strategies for successful Trial Master File (TMF) delivery and associated long term records management. Defines both CRO partnership and TMF outsourcing strategies in support of Takeda partnership oversight activities, study deliverables and successful regulatory filings. The Director is responsible for resource management (budget and headcount), development of their staff, and for leading an organization of continuous improvement and driving a culture best practice to TMF industry standards.
With a focus on inspection readiness, collaborates with Clinical Support team, Functional Area Heads and QAC in the preparedness, support and deliverables associated with GCP Health Authority Inspections.
- Leads clinical document management team in establishing strategic direction and operational management of TMF, including, process renovation, system & technology, inspection readiness, and outsource & vendor governance.
- Collaborates with Global Development and Operations Functional Leads to gain alignment on long range innovative strategies for clinical document management.
- Contributes to strategies for the planning and execution of regulatory inspections to ensure optimal outcomes for Takeda. May directly serve as subject matter expert and present/attend regulatory inspection.
- Ensures appropriate long term clinical records retention that meets regulatory requirements and oversees execution of records identifying, transfer or ingestion in support of Takeda’s submissions, acquisitions and divestments.
- Establishes functional goals which support company objectives and long-term strategic plans
- Manages the decision- making process, issue escalation and resolution, and ensures effective flow of information between senior leaders both internal and external related to document management issues and inspection readiness which impact GDO.
- Monitors compliance and considers corrective and preventative actions where necessary.
- Continually monitors industry trends to influence competitive with innovative strategies for Trial Master File management.
- Ensures effective team collaboration with Takeda’s CRO partners related to delivery of Takeda’s Trial Master File portfolio.
- Defines and oversees execution of strategies for TMF and associated clinical records retention ensuring alignment with Takeda’s corporate policies and regulatory requirements
- Responsible for direct line management, mentoring and development of CDM Managers who oversee internal and external team(s). Serves as escalation pathway for performance issues and/or related process.
- Develops resourcing and budgeting forecasts related to CDM
- Oversees development of SOPs, Takeda Policies and training strategies associated with Trial Master File management, serves as TMF process owner ensuring alignment with eTMF systems strategies and Takeda policies for Records and Information Management.
- Promotes a positive, results-driven environment which models teamwork and provides visibility into successes.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelor’s Degree or international equivalent required; Life Sciences preferred.
- Minimum 10+ years’ experience in clinical operations with a thorough understanding of cross functional clinical processes.
- Comprehensive knowledge of regulatory requirements governing clinical trial document management and industry best practices is essential.
- Experience establishing and leading teams
- Demonstrated successful experience in project/program management and matrix leadership
- Good communication skills
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Demonstrated ability to develop and propose independent plans and strategies sufficient to gain alignment with senior management and other functional leads.
- Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners and in support of regulatory inspections.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.