Clinical Document Manager

Advanced Clinical; San Francisco (CA); Remote; USD 150,000 - 200,000; Full time

Job summary

Join a forward-thinking clinical development organization as a Clinical Document Manager, where you'll play a pivotal role in ensuring the integrity of clinical trial documentation. This exciting opportunity allows you to leverage your expertise in Good Clinical Practices and regulatory standards while managing Trial Master Files and collaborating with cross-functional teams. Your contributions will directly impact the quality and compliance of clinical trials, making a significant difference in the industry. If you're passionate about clinical research and thrive in a dynamic environment, this role offers the chance to excel in your career while supporting innovative healthcare solutions.

Qualifications

• 8+ years in pharma/biotech with 3+ years in TMF management.
• Expertise in GCPs, ICH standards, and FDA regulations.

Responsibilities

• Maintain TMF structures and ensure document availability for audits.
• Manage user access, archival repositories, and document retrieval.
• Conduct quality control reviews of key clinical documents.

Skills

Good Clinical Practices (GCPs)

International Conference for Harmonization (ICH) Standards

FDA Code of Federal Regulations

Clinical Trial Master File management

Analytical skills

Problem-solving skills

Interpersonal skills

Communication skills

Flexibility and adaptability

Education

Bachelor’s Degree

Tools

Veeva Vault eTMF

eTMF systems

Job description

OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Document Manager remotely in the United States. The Clinical Document Manager role will ensure each Trial Master File can fully reconstruct the conduct of a clinical trial and those documents are readily available for audits/inspections. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

1. Ensure defined TMF file structure(s) are maintained and secure. Create new TMF structures when needed.
2. Serve as Veeva Vault eTMF technical specialist.
3. Provide quality control reviews of key clinical documents (e.g., protocols and ICFs).
4. Manage user access and organization of TMF, archival repositories, and offsite storage location.
5. Manage retention and destruction schedules of maintained and offsite storage TMFs.
6. Manage off-site archiving activities (including budget, cataloguing process, and document retrieval).
7. Manage document index to ensure all on-site and off-site documents can easily be retrieved.
8. Define, execute, and manage TMF system migrations and associated Quality Control processes.
9. Define and manage necessary vendor oversight that includes performance and quality metrics, ensuring they meet ICH guidelines and global regulatory requirements. Ensure TMF metrics are reviewed and distributed.
10. Propose and contribute to process design, implementation, and hands on TMF activities that ensure quality documentation and system maintenance.
11. Support clinical trial managers and other Company contributors to ensure ongoing content management of the TMF.
12. Ensure vendors perform to our document quality standards and expectations. Oversee CRO conducted TMF activities and file reviews.
13. Partner with study teams to facilitate appropriate vendor oversight and quality control procedures throughout the lifecycle of a trial, including appropriate oversight for all contributors to the TMF.
14. Perform periodic reviews of TMF to ensure adherence to standards and compliance with relevant regulations, guidelines, and standards.
15. Plan and manage oversight review of the CRO TMF, including tracking of all findings through closure.
16. Manage the exchange of TMF documents with external service providers.
17. Perform initial and/or in-process assessment of vendor standard operating procedures, and document the review as requested.

EXPERIENCE

Minimum of 8 years of experience in the pharmaceutical, biotechnology or medical device industry with at least 3 years' experience in Clinical Trial Master File management is required.

EDUCATION

Minimum of Bachelor’s Degree required. Equivalent experience may be accepted.

To be a best-fit your strengths must include:

1. Expertise with Good Clinical Practices (GCPs), International Conference for Harmonization (ICH) Standards, and FDA Code of Federal Regulations for clinical trials.
2. Strong knowledge of global regulatory requirements and ICH/GCP guidelines.
3. Knowledge of clinical research study design and ability to answer technical questions related to tips, techniques and problem solving around TMF.
4. Specific knowledge of Veeva eTMF is required. "White belt" certification preferred. Knowledge of multiple eTMF systems preferred.
5. Highly proficient with software capabilities and business applications.
6. Experience in management of multiple global clinical trial programs is highly desired.
7. Experienced in handling trial essential documents is required.
8. Possesses demonstrated ability to supervise others, either directly or in a project matrix/oversight scenario.
9. Strong interpersonal skills with a demonstrated ability to interact with many levels of technical and business staff.
10. Excellent analytical, problem solving, and organizational skills are required.
11. Ability to establish excellent internal and external relationships, including vendors.
12. High level of flexibility and ability to adapt to changing conditions.
13. Good oral and written communication and interpersonal skills.

About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.