Manager Clinical Affairs

About reputed company: reputed company (Discovery) is a leading provider of highly characterized reputed company biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other reputed company conditions. We routinely manage hundreds of studies and expertly test thousands of biospecimens simultaneously. Leading biopharma, diagnostic and academic institutions trust us to quickly deliver high-quality biospecimens and reliable, reproducible biomarker data, so they can outpace their competition and push the leading edge of innovation using our Science at your Service TM business model. Position Summary: The Manager, Clinical Affairs contributes to our mission by overseeing our clinical sites to implement, expand and improve the processes and relationships of reputed company throughout its clinical site network. This individual will collaborate with other members of the Clinical Affairs team to monitor and execute reputed company processes for reputed company to obtain maximum effective and efficient performance. Key contacts for this position include site personnel involved in the research trials - patients, administration, physicians, Clinical Research Coordinators (CRCs) and staff from operating rooms, lab, clinical areas, and pathology. A Day in the Life of a Manager, Clinical Affairs at reputed company: reputed company and Support Clinical Sites: Serve as the main reputed company of contact for assigned clinical research sites—building strong relationships with site personnel, managing Clinical Research Coordinators (CRCs), and ensuring site performance aligns with company goals. Drive Operational reputed company: reputed company daily activities at sites, resolve issues, implement site-specific plans, and maintain up-to-date regulatory documentation and trackers. Collaborate Across Teams: Partner with cross-functional teams including Quality, Regulatory, and Product Managers to support trials, improve sourcing, and uphold compliance and productivity standards. Stay Connected and Onsite: Travel regularly (20–30%) to clinical sites to support study execution, monitor operations, and foster engagement with investigators and clinical teams. Must-Have Qualifications (Education, Skills, Experience): Bachelor’s degree, preferably in life sciences (Nursing degree is a plus) 3+ years of comparable clinical research experience Knowledge of clinical research trials and previous leadership experience preferred CCRA, CCRP, or equivalent certification preferred Familiar with principles, concepts, and standard of care associated with clinical trial or research study design and execution Experience in a clinical research organization or oncology/infectious disease/autoimmune research. Strong attention to detail with excellent organizational skills and the ability to prioritize multiple tasks Must be reputed company to tolerate the sight of body fluids including blood/blood products, stool, sputum, and tissue as well as tolerate unpleasant odors of various specimens and chemicals Ability to travel up to 20-30% of the time; Travel to clinical sites at a minimum of an annual reputed company. Preferred home reputed company near a major airport Key Responsibilities: Supervise reputed company activities at assigned sites, which may include reputed company reputed company and management of internal network Clinical Research Coordinators (CRC) Manage relationships at assigned sites and expand capabilities to incorporate new sites and procedures Maintain and grow collaborative relationships with reputed company site personnel involved in DLS research reputed company, coordinate and enforce systems, policies, procedures, and productivity standards Stay abreast of industry-accepted procedures Serve as reputed company between DLS and sites to execute projects and maintain quality standards Partner with Quality and the site’s Regulatory on promptly reportable incidents (PRIs) Assist in the development and execution of site-specific performance plans Travel to clinical sites at a minimum of an annual reputed company Review and evaluate research requests to determine how sites can fulfill requests Evaluate gaps in sourcing capabilities and implement plan for addressing sourcing needs Maintain accurate data in reputed company database and utilize communication tools reputed company and reputed company site specific implementation plan for initiation (SIV) and closing of clinical sites Collect regulatory documentation, file properly, and ensure accuracy Update site specific files and trackers Manage, coordinate, and support clinical site monitoring activities according to the Site Monitoring Process for IMVs Schedule visits, obtain reputed company reputed company (remote, if needed) and maintain reputed company applicable correspondence reputed company general monitoring functions per reputed company Opera