Clinical Coordinator

Duration: Contract till June 2027 with possibility to extend Shift: 1st, Monday thru Friday (8am to 4 PM) Note: Watson LIMS is Must Required (Very Important) Candidate relocation preference Possibly extension open to candidates willing to relocate at own expense, however strongly prefers local candidates. Job Description The Clinical Contract Coordinator (CCC) will organize the biological specimen management laboratory, reception, registration, storage, and shipment of biospecimen for pre‑clinical and clinical studies received at a Laboratory Site. The CCC will also be secondarily assigned to clinical studies and may be responsible for the collection, processing, storage, and distribution of biological specimens in support of clinical research and development programs. This role ensures compliance with regulatory requirements, quality standards, and ethical guidelines while managing biospecimen operations across multiple studies and sites. As a CCC you will report directly to the Global head of the Translational Medicine Operations BSM department or a delegated team lead and will collaborate closely with the global translational medicine operations biospecimen management team and other stakeholders such as local site head of lab sciences, scientists, Precision/Biomarker/PK/ADA leads, clinical operations study/project leads, data leads, biomarkers & bioanalysis outsourcing team. Local Site Laboratory Management Responsibilities You will be responsible for the day‑to‑day coordination and management of laboratory sample operations, ensuring accurate receipt, processing, storage, and tracking of biological specimen. Receive, record, store, dispose, and ship Biospecimen addressed to the laboratory from across global locations and verify the compliance of the related delivery documentation. Ensure and perform the registration of pre‑clinical/clinical study Biospecimen received in our LIMS (Laboratory Information Management System e.g. Watson) and generate and send documents related to these receptions. Manage the recording of receptions and shipments in dedicated tracking files. Detect, analyze, and report inconsistencies during Biospecimen reception and registration to the study Biospecimen Manager who will support you in resolving these inconsistencies. Ensure the creation of study designs in Watson LIMS. Ensure the maintenance of the BSM laboratory work areas and proper functioning of equipment. Ensure work quality in accordance with Good Laboratory and Clinical Practices (GLCP). Monitor regular equipment maintenance and update established documentation. Ensure and perform registration and update of inventories (Biospecimen, equipment, and consumables). Continuously participate in improving the department's operations and ensure that safety instructions are followed as the Health Safety Environment (HSE) correspondent for BSM. Create and/or update BSM procedures. Participate in meetings and working groups, propose technical, organizational, and documentary improvements, and participate in process optimizations. Support audits and inspections; act as spokesperson for sample‑related processes and documentation. Global Biospecimen Management and Responsibilities As a CCC you may be assigned to perform the Biospecimen management tasks, monitor clinical studies and oversee end‑to‑end biospecimen lifecycle from collection through analysis and archival. Implement Translational Medicine and biospecimen management strategies aligned with clinical development objectives. Partner with clinical study teams to integrate biospecimen requirements into study protocols. Collaborate with translational medicine and biomarker teams on biospecimen utilization. Review study documents such as the protocol, Informed Consent Form, central laboratory specifications, electronic Case Report Form (eCRF) specifications, data collection strategy, etc. Lead the design and optimization of biospecimen collection protocols and workflows. Create the Biospecimen Management Plan (SMP) containing instructions for collection, storage, and shipping of Biospecimen. Manage relationships with the Bioanalysis outsourcing, central laboratories, biorepositories, and third‑party vendors as needed. Ensure proper chain of custody, tracking, and inventory management of all biospecimens. Create reports containing Biospecimen statuses and perform overall monitoring of these Biospecimen, from collection to destruction. Ensure the traceability of associated documentation in the electronic Trial Master File (eTMF). Education Bachelor’s degree required in Biological Sciences, Biomedical Sciences, Biotechnology, Clinical Laboratory Science, Public Health and Life Sciences or related field. 3‑6 years’ experience in biospecimen management, clinical laboratory operations managing biospecimens in clinical trials or research settings. Skills Sample coordination experience, sample receiving, and sample related work, biospecific with clinical trials. Minimum 3 years of professional experience (Master’s degree acceptable, PhD overqualified). Biospecimen and lab operations expertise with end‑to‑end lifecycle management, workflow coordination, timeline planning, and strong cross‑functional collaboration. Experience supporting clinical trials, including sample management and use of LIMS (e.g., Watson) and specimen tracking systems. Solid knowledge of regulatory and quality standards, including GCP, GCLP, CLIA, CAP, and ICH‑GCP guidelines. Proficiency with Laboratory Information Management Systems (LIMS) and specimen tracking platforms. Experience with clinical trial sample management. Knowledge of ICH‑GCP guidelines and regulatory requirements. Familiarity with Clinical trial management & electronic data capture (EDC) systems. May require flexibility to support urgent sample processing needs. Manual dexterity, strong communication, team management capabilities and fluency in English. Experience with global, multi‑site clinical studies preferred. Experience with biospecimen banking or biorepository operations preferred. #J-18808-Ljbffr