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Worldwide Clinical Trials

Manager, Clinical Operations Site Management (Franchise Lead) - CNS - U.S.

Worldwide Clinical Trials

4h ago

No Phone Required$112k - $222kManagementUnited Stateshimalayas
Clinical-OperationsSite-managementClinical-Research-ManagementClinical-Project-ManagementFranchise-LeadClinical-Operations-ManagerClinical-Operations-LeadClinical-Study-Operations-ManagerSenior-Clinical-Operations-LeadManager

Job Description

Who we areWe’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.Why WorldwideWe believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!What the Franchise Lead - CNS does at Worldwide Clinical TrialsThe Manager, Clinical Operations Site Management (Franchise Lead) is responsible for providing on‑time and quality delivery of site management services from assigned Clinical Research Associates (CRAs) within assigned therapeutic area(s) and program(s)What you will doProvide therapeutic and operational expertise throughout the program and project delivery lifecycleEnsure that projects within the franchise are properly resourcedCollaborate with the therapeutic team to create effective delivery strategies and solutions for franchise projects and programsAct as the main contact person for the Project Management Franchise LeadPresent at proposal defense and client meetings as needed to support new or ongoing businessEnsure CRAs are trained on project specificsEnsure Lead CRAs (LCRAs) are trained to support the clinical scope of work, including standard operating procedure (SOP) review, quality issue (QI)/corrective and preventive action (CAPA) understanding, and the Clinical Monitoring PlanCoordinate and collaborate with Worldwide Clinical Trials Global Quality Assurance to provide training opportunities identified through CAPA informationManage the quality of the assigned staff’s clinical workCoordinate efforts between Project Management, Site Management, and Study Start‑UpEstablish regular communication to include quality metrics (such as site visit report compliance, source data verification metrics, and on‑site metrics) and overall project “health” metrics (such as data query status, adherence to the scope of work, and resource status)Conduct performance appraisals for direct reportsThe duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.What you will bring to the roleBroad protocol knowledge; therapeutic knowledge preferredComprehensive global knowledge, awareness, and practical understanding of the biopharma industry, drug development lifecycle, and operational clinical trial deliveryInnovative and strategic thinkerSuperior oral and written communication skillsStrong planning and organizational skillsStrong interpersonal skillsExperienced problem‑solving and decision‑making skillsStrong attention to detailUnderstanding of clinical research principles and processes, including data collection and editing skillsAbility to navigate Electronic Data Capture (EDC) software such as InForm and MedidataStrong knowledge of U.S. Food and Drug Administration (FDA) regulations, International Council for Harmonisation (ICH) guidelines, and the Health Insurance Portability and Accountability Act (HIPAA)Understanding of standard operating proceduresYour experienceFour‑year college curriculum with a major concentration in biological, physical, health, pharmacy, or other related sciences, and eight years of clinical research experience as a clinical research associate, OREquivalent education and training with ten years of clinical research experience as a clinical research associateTwo or more years of management experienceExtensive CNS experience requiredTravel requiredPassport requiredPromotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $112,000.00 - $222,000.00The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range,