TMF Manager

Temp TMF Manager

Pay Range: $52.88 - $87.02/hr

Remote Role (US Only)

6 Month Contract

The TMF Manager will be accountable for driving and managing TMF Health (quality, completeness and timeliness) across Therapeutic Area portfolios to ensure TMFs are always inspection ready. Ensuring CTM and Global Development (GD) Quality leadership are informed, understand the impact of metrics and the required action plans for remediation. Accountable for working with the Clinical Study teams to develop appropriate actions to improve TMF Health and resolve TMF documentation issues. Advocates and promotes active TMFs to support decision-making with all internal and external stakeholders, escalating as necessary. Central point of contract for assigned Clinical Research Organization.

Serve as TMF Lead on critical and high priority studies as assigned.

A typical day as a TMF Manager may look like:

• Accountable for driving and managing TMF Health (quality, completeness and timeliness) across Therapeutic Area portfolio to ensure TMFs are always inspection ready.
• Ensure CTM and GD Quality leadership are informed and understand the impact of metrics and the required action plans for remediation.
• Portfolio Point of Contact for assigned Clinical Research Organization
• Develop and promote actions for the study teams to improve TMF Health and resolve TMF documentation issues.
• Advocates and promotes active TMFs to support decision-making
• Advocate and promote TMFs to be always inspection ready with all internal and external stakeholders.
• Collect and escalate study TMF issues as necessary to internal CRO counterparts and work with them to resolve.
• Serve as the steward of the study eTMF and as the TMF SME to ensure the processes detailed in the TMF Plan supporting TMF Health (completeness, quality and timeliness) are followed by the study team.
• Effectively communicate and drive document management compliance, quality issues and TMF Health metrics to the clinical study teams and management.
• Present eTMF at study Kick-off, investigator and TMF initiation meetings and attend regular study team meetings as applicable to report on the status of the TMF.
• Prepare the study specific TMF plan and corresponding study inventory list and insure they are current throughout the study and finalized at study completion.
• Ensure TMF reviews (TMF Inspection Readiness and Expected Document Lists) are conducted as prescribed in the TMF plan and that issues identified are addressed.
• Address general questions or training needs from the CRO/study team functional areas.
• Own special projects within the TMF organization (Process improvements, Study Inventory List Management, etc.) and work with management for continuous improvement.

This role may be for you if you have:

• A demonstrated, deep understanding of the TMF Reference model and processing of documentation into the eTMF system.
• Demonstrated ability to prioritize and manage multiple projects simultaneously
• Demonstrated ability to work effectively with many different types of personalities at all levels of the organization
• Excellent interpersonal, collaboration and stakeholder management skills
• Excellent communication skills (written/verbal)
• Highly self-motivated, flexible, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure
• Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking
• Highly proactive, flexible, curious and resilient
• Proficient in Microsoft Applications; Word, Excel, Project, and PowerPoint
• Ability to travel (<10%)

In order to be considered qualified for this role a minimum a Bachelor’s degree or equivalent is required and 5 years of experience

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation