Clinical Document Manager
Clinical Document Manager
Posted on :
30-01-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
30-01-2025
Job Description
Job Title: Clinical Document Manager
Job Location: San Francisco CA USA
Job Location Type: Remote
Job Contract Type: Contract
Job Seniority Level: MidSenior level
Overview
We are currently searching for a skilled professional to join a wellknown 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
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 Bestfit Your Strengths Must Include
Advanced Clinical is an awardwinning 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
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.
511208
We are currently searching for a skilled professional to join a wellknown 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
- Ensure defined TMF file structure(s) are maintained and secure. Create new TMF structures when needed.
- Serve as Veeva Vault eTMF technical specialist.
- Provide quality control reviews of key clinical documents (e.g. protocols and ICFs)
- Manage user access and organization of TMF archival repositories and offsite storage location.
- Manage retention and destruction schedules of maintained and offsite storage TMFs.
- Manage offsite archiving activities (including budget cataloguing process and document retrieval)
- Manage document index to ensure all onsite and offsite documents can easily be retrieved.
- Define execute and manage TMF system migrations and associated Quality Control processes.
- 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.
- Propose and contribute to process design implementation and hands on TMF activities that ensure quality documentation and system maintenance.
- Support clinical trial managers and other Company contributors to ensure ongoing content management of the TMF.
- Ensure vendors perform to our document quality standards and expectations. Oversee CRO conducted TMF activities and file reviews.
- 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.
- Perform periodic reviews of TMF to ensure adherence to standards and compliance with relevant regulations guidelines and standards.
- Plan and manage oversight review of the CRO TMF including tracking of all findings through closure.
- Manage the exchange of TMF documents with external service providers.
- Perform initial and/or inprocess assessment of vendor standard operating procedures and document the review as requested.
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 Bestfit Your Strengths Must Include
- Expertise with Good Clinical Practices (GCPs) International Conference for Harmonization (ICH) Standards and FDA Code of Federal Regulations for clinical trials.
- Strong knowledge of global regulatory requirements and ICH/GCP guidelines.
- Knowledge of clinical research study design and ability answer technical questions related to tips techniques and problem solving around TMF.
- Specific knowledge of Veeva eTMF is required. "White belt" certification preferred. Knowledge of multiple eTMF systems preferred.
- Highly proficient with software capabilities and business applications.
- Experience in management of multiple global clinical trial programs is highly desired.
- Experienced in handling trial essential documents is required.
- Possesses demonstrated ability to supervise others either directly or in a project matrix/oversight scenario.
- Strong interpersonal skills with a demonstrated ability to interact with many levels of technical and business staff.
- Excellent analytical problem solving and organizational skills are required.
- Ability to establish excellent internal and external relationships including vendors.
- High level of flexibility and ability to adapt to changing conditions.
- Good oral and written communication and interpersonal skills.
Advanced Clinical is an awardwinning 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
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.
511208
/jobs/view/ab53daecc3c99e0f338c7f
Employment Type
Full Time
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
