Are you looking to make a difference in the lives of patients? Are you passionate about healthcare and providing medicines to patients in need? If so, we have an exciting opportunity for you At WEP Clinical, we are dedicated to groundbreaking projects that are transforming the world day by day. Join us and witness the impact you can make Role Objectives The WEP Clinical Documentation C oordinator is responsible for processing program documentation in accordance with Standard Operating Procedures (SOPs), GCP, ICH guidelines, and study-specific TMF plans, as well as processing and maintaining shipping documentation. The ideal candidate has: Attention to detail Strong multitasking abilities Excellent organizational skills Proficient problem-solving skills What You'll Do: Track, obtain, and file shipping related documents according to WEP and program specific requirements. Collaborate with internal teams to ensure seamless order processing, documentation retrieval and filing. Responsible for maintaining systems and tools for evaluating, tracking, and transmitting trial master file documents. Conduct eTMF content reviews and provide TMF/eTMF content reports to the internal project management team and management on a regular basis. Ensure that WEP Clinical privacy and security standards are met and adhered to. Ensure that documents are maintained in accordance with WEP Clinical retention practices. Assist with maintaining up-to-date study status tracking and other tracking tools (as assigned). Proofread documents upon request and perform other administrative tasks as necessary. Label, sort, and categorize documents for ease of use, develop archiving system, and retrieve documents upon request. Outline long-term document storage strategies, work with colleagues to ensure consistency of documentation practice across the company, and train employees on efficient documentation usage as necessary. Assist in routine internal and external master file audits to ensure compliance with applicable work instructions, Standard Operating Procedures (SOPs), policies, Procedures and guidelines. Scan (or coordinate scanning) of documents. Label scanned documents and import into internal systems to ensure availability. Conduct detailed and appropriate quality checks (QC) on eTMF documents at defined time points, including any paper originals required. Support electronic Trial Master File (eTMF) set-up, maintenance, update, archival and closeout in accordance with WEP Clinical processes, Sponsor requirements, and applicable regulations. Process shipment orders (if applicable) according to WEP and program-specific requirements What You'll Need: Bachelor’s Degree, preferred Experience with managing clinical study documents using best practices pertaining to clinical trial document management and archiving (preferred) Experience with clinical study electronic databases (preferred) 2-3 Years experience of order processing and documentation management systems, preferred What We Offer: 25 days annual leave Vitality Healthcare Discretionary bonus Free fruit/Breakfast in the office Death In Service x4 of base salary Salary sacrifice pension Summer hours between May and August Happy Hour Volunteer day Length of service awards Training Allowance Quarterly, Summer & Christmas Parties Free Parking What sets us apart: WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over a decade of experience distributing products worldwide to treat unmet patient needs. As a valued member of our team, you will have the opportunity to contribute to groundbreaking clinical research projects that shape the future of healthcare. We're Committed to Our Team: WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, all that we do to support our employees. We're Committed to DEI: At WEP Clinical, acceptance, recognition, and engagement are at the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth and to embracing everyone's unique identities. Our services include: Expanded Access Programs (EAPs) Named Patient Programs (NPPs) Clinical Trial Supplies (Comparator & Ancillaries) Wren Nursing (Clinical Trial Home Nursing & Clinical Education) Hospital Supply of Unlicensed Medicines WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment. WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.