Manager, Trial Master File (TMF) Operations
Manager, Trial Master File (TMF) Operations
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Salary Not Disclosed
1 Vacancy
Job Description
The Role:
The Manager TMF Operations will support the implementation of Decipheras TMF operational strategy TMF processes and TMF services by collaborating with and supporting external and internal team members to ensure an inspection-ready TMF
What You Will Do:
- Implements and ensures compliance with all TMF controlled procedural documents (i.e. SOPs Work Instructions Templates and Forms).
- Supports cross-functional trial teams with TMF processes TMF plans and TMF filing.
- Ensures TMF completeness metrics are met.
- Assist study teams in preparation for TMF audits and TMF regulatory inspections.
- May support TMF process improvement initiatives to increase departmental TMF execution and effectiveness.
- Tracks and trends TMF KPIs metrics and overall completeness.
- Documents communicates and escalates risks to Line Manager and Clinical Operations and applicable.
- Demonstrates excitement around the Vison and Mission of Deciphera and the department
- Other duties as assigned
Qualifications :
What You Will Bring:
- Bachelors degree or equivalent required (scientific or technical discipline preferred).
- Minimum of 5 years of clinical operations/development experience with a minimum of 2 years of direct TMF or Records management experience.
- Prior in-house eTMF experience required.
- Prior TMF experience at the Manager level.
- Demonstrated understanding of clinical trial related documentation.
- Mastery of global regulatory requirements and guidelines for conducting clinical research in accordance with ICH-GCP 21CFR Part11 and other applicable regulations.
- Experience supporting or participating in GCP inspections (e.g. FDA EMA MHRA) preferred.
- Ability to network and build relationships to maximize organizational function and capabilities.
- Strong verbal and written communication skills are required.
Additional Information :
Benefits:
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical dental vision insurance 401(k) retirement plan with company match and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
