Contract, TMF Specialist

Location: It's a virtual position but possibly work on site in South Plainfield, NJ 2x a week the most. So local candidate (South Plainfield) would be preferred.

Duration: 6 months contract (there are possibilities of conversion or extension of contract)

Experience required:

• 3+ years of eTMF experience - closer to the Lead level, not an entry/support position.
• Solid understanding of ICH and FDA regulations around Clinical Trials and trial documents/eTMF.
• Strong technical aptitude.
• What eDMS or eTMF systems do you have?

• Must have TMF experience along with the TMF Reference Model.

The Contract TMF Specialist collects, reviews, files, maintains and archives essential regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 International Conference on Harmonisation (ICH) Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, European Medicines Agency (EMA) Clinical Trials Directives), and company Standard Operating Procedures (SOPs) as appropriate. Essential regulatory documents include, but may not be limited to: externally-sourced documents from clinical investigators, Institutional Review Boards (IRBs)/ethics committees, competent authorities, etc., and internally-sourced documents (e.g., clinical protocol, Data Management Plan [DMP], Statistical Analysis Plan [SAP], etc.) for domestic and international clinical studies. The incumbent works cross-functionally with internal departments and external resources on Clinical Documentation related issues. The Contract TMF Specialist supports adherence to relevant regulatory requirements and company SOPs as appropriate.

ESSENTIAL FUNCTIONS

• Works with multi-functional teams (internal and external) to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.
• Tracks effective and expiration dates of external documents (e.g., clinical laboratory certifications, Medical Licenses, and curriculum vitae [CVs]). Collects, reviews, and indexes essential documents in accordance with TMF structure.
• Uploads TMF documents into the eDMS and/or other document files, e.g., as "working documents" while the study is ongoing. Acts as TMF Subject Matter Expert (SME) and point-of-contact for study teams and TMF stakeholders.
• Provides oversight of Contract Research Organization (CRO)/ Vendors when TMF is outsourced.
• Provides support and TMF guidance during audit and/or inspections. Performs other tasks and assignments as needed and specified by management

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

• * Minimum level of education and years of relevant work experience. High school diploma and a minimum of 3 years of relevant professional experience with essential regulatory documents in a pharmaceutical, biotechnology, CRO or related environment. * Special knowledge or skills needed and/or licenses or certificates required. Thorough knowledge of essential regulatory documents required for the conduct of clinical studies, as described in the ICH E6 Guidelines and in relevant regulations (e.g., Food and Drug Administration (FDA) 21 CFR). Knowledge and working experience with TMF Reference Model. Proficiency with Microsoft Office. Excellent verbal and written communication and skills. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. *Special knowledge or skills and/or licenses or certificates preferred. Associate's and/or Bachelor's degree. Experience using eDMS software. Demonstrated experience identifying, developing, and implementing improvements to departmental processes that increase efficiency and that maintain or improve quality (e.g., increasing the numbers of documents processed). Demonstrated ability to identify opportunities to improve study sites' processing of essential regulatory documents. This includes communicating recommended changes to the sponsor's study management and site monitoring staff.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

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Company Profile:

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.

We look forward to working with you!

Beacon Hill. Employing the Future™