Manager, Records Management (TMF Quality Control Specialist)

About Codera 

Codera is a Tang Capital company that provides in-house end-to-end drug development for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. 

Position Summary

The Manager, Records Management (TMF Quality Control Specialist) will provide support for TMF activities by ensuring documents uploaded to the TMF adhere to Standard Operating Procedures, ICH GCP guidelines and other regulatory requirements. The Manager will act as a TMF Subject Matter Expert (SME) and work with the study teams to ensure the TMFs and CTMS for clinical studies are inspection ready at all times.

Primary Responsibilities

Review study documents received from the study teams for completeness and accuracy and upload to the Trial Master File (TMF)

Perform quality control of documents submitted to the TMF per SOPs, Work Instructions and Guidance Documents.

Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed.

Perform TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times.

Provide feedback, support and training to study teams to build knowledge and awareness of good, quality documentation management practices for clinical trials.

Conduct TMF educational workshops/training, as needed.

Address TMF questions pertaining to how documents are filed, and user questions related to the TMF system.

Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.

Perform the secondary review of site Essential Document Packages per applicable SOPs to ensure sites meet the requirements for site activation and Investigational Product (IP) release.

Responsible for Clinical Trial Management System (CTMS) maintenance, including study, country and site level updates and reviewing CTMS entries for accuracy.

Contribute to TMF QC Tools as needed to match with evolving business processes (incl. QC Tool, QC Manual, Doc Owner Manual, TMF Newsletters).

Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory considerations as applicable to the job duties.

Assist with inspection/audit related activities (e.g., preparation, corrective action plans).

Execute other duties as assigned.      

Qualifications

Minimum 2 years of relevant clinical research and TMF experience required

Understanding of the clinical trial process, experience in handling clinical trial related documents required

Previous experience in electronic TMFs, Veeva preferred

Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management

Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills

Demonstrated ability to achieve high performance goals and meet deadlines in a fast- paced environment

Strong organization skills with outstanding attention to detail and follow-through

Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities

Demonstrated proactive approaches to problem-solving with strong decision-making capabilities

Must be fully proficient in MS Office Suite and internet research

The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice. 

The estimated annual base salary for this position is $115,000 - $145,000, commensurate with experience and skills. 

Codera provides a comprehensive benefits package designed to support employees’ physical, mental and financial health and includes employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs.

Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. 

Codera participate in E‑Verify. All newly hired employees are required to complete the E‑Verify process as part of their employment eligibility verification.