Trial Master File Manager
We are currently searching for a skilled professional to join a well-known client’s team as a Trial Master File Manager. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Manages document control processes and systems for GCP activities in compliance with internal procedures and policies and ensures compliance with ICH/GCP and relevant legislation and regulations
- Responsible for assessing suitability of documentation for filing (accuracy, completeness, and legibility) and archival of clinical trial documents
- Manages the user administration and conducts training of the e-Trial Master File process to internal and external stakeholders
- Ensures high quality e-Trial Master File set-up and management (on-boarding of study contributors, completion of the e-Trial Master File management plan, study specific preparation of documents in the system, periodic reviews, etc.)
- Serves as an e-Trial Master File contact for documentation to the project team and cross functional departments
- Follows up on open record management queries and ensures their full resolution
- Assists in periodic e-Trial Master File audits
- Plans and performs internal periodic quality check (QC) activities of the e-Trial Master File, provides findings to the clinical team and provides support to the team to ensure compliance is maintained to meet internal and external quality standards
- Provides support to clinical teams during regulatory inspections for record organization and retrieval
- Acts as the Subject Matter Expert for the e-Trial Master File process, ensuring that project documentation is maintained to the highest level of quality and compliance while aligning with company and departmental objectives
- Continuously monitors, identifies and reports quality problems and record management work practices, make recommendations for resolutions, and initiate actions required to resolve quality and efficiency problems
- Travel may be required and estimated at approximately 10%
- Minimum of three years of experience in Clinical eTMF management
- Understanding of drug development process
- Strong knowledge of ICH-GCP guidelines and FDA/EMA/PMDA regulations
- Previous experience overseeing eTMF audits, internal and/or regulatory audits
- Excellent working knowledge of clinical study documentation
- Experience in overseeing and training employees on eTMF SOPs and regulatory requirements
- Strong software and computer skills, including Microsoft Office applications (Word, Excel, Outlook), eTMF and eClinical technologies
- Excellent understanding of system data structures and Clinical Document Management System functionality
- Outstanding organizational skills with the ability to multi-task and prioritize in a fast-pace environment
- Excellent attention to accuracy and details
- Effective written and verbal communication skills
- Solid analytical and proactive problem-solving skills
- Strong operational skills and demonstrated ability to meet timelines
- Bachelor’s degree preferred; Professional Records Manager Degree is an advantage
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
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.