TMF LEADERSHIP: Steward Continuous Improvement Through a Oversight and a Shared Culture of Quality With Internal and External Allies
The onus to ensure Quality and Inspection Readiness is on TMF leaders. Within their purview are the creation and establishment of systems, the procurement and provisioning of resources, and stewardship of eTMF and paper-based systems. The state of a TMF is determined by a multitude of factors that include processes and information management practices that the TMF steward has agreed to. But the TMF Steward must synthesize an understanding of company culture, team-based leadership, staffing, operations, regulations, CRO partners and so forth into a comprehensive TMF executive strategy.
This course will enhance participants’ ability to analyze, assess and think strategically and lead partners and internal allies to autonomy. This course will look at the pros and cons of CRO partnerships according to case studies that spotlight nuanced needs, benefits and risks. Participants will be better prepared to develop and adapt plans throughout the clinical life cycle. Participants will assess a variety of situations including mergers and acquisitions, changing requirements, and other situations for their impact on Quality and Inspection Readiness and that may jeopardize fidelity to the TMF Management Plan.
Upon completion of this course, participants will know or be able to:
- Assess various partnership models to determine third-party partner strategy
- Convey TMF executive strategy to constituencies in tailored communications
- Build and manage cohesive cross-functional teams
- Foster autonomy through staff selection and development
- Vet CROs and other third parties based on their ability and suitability
- Establish processes to conduct KPI-driven Quality reviews
- Conduct collegial and constructive follow-up after a mock inspection
- Tailor the TMF Management Plan and streamline processes throughout the study life cycle
- Establish position titles, roles and responsibilities to support the management of TMF, GCP and partnerships
- Establish milestones for piloting, implementing and executing eTMFs
- Provide justification of resource allocation for a TMF management structure
*This course includes a continental breakfast at 8AM, two networking breaks and lunch.
Brian Souder, TMF Head, MERCK
Liz Farrell, Senior Manager, TMF, BIOGEN
Shayna Lambert, Director, Head of TMF CoE, The Janssen Pharmaceutical Companies of Johnson and Johnson
Jennifer Maier, Associate Director, R&D Quality Compliance, ALEXION
Perry Steinberg, Regulated Content Management Product Leader, MEDIDATA
Stephanie Viscomi, Associate Director, Clinical Trial Office, IMMUNOGEN