Senior Clinical Project Manager

Clinchoice

📍 DE0🕐 today

Role overview

Clinchoice is hiring for the Senior Clinical Project Manager role in DE. It is a position, Senior level, in the Healthcare sector. It was posted today.

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Role: Senior Clinical Project Manager
Company: Clinchoice
Location: DE
Work mode: On-site
Seniority: Senior
Sector: Healthcare
Posted: today

Description

ClinChoice is a global full-service CRO recognized for its commitment to professional development, strong work-life balance, and a collaborative, quality-driven “one-team” culture. We are currently seeking a Senior Clinical Project Manager to support projects across pharmaceutical, biotechnology, medical device, and consumer health clients, ranging from emerging companies to large global organizations. In this role, you will lead cross-functional teams and oversee the execution of complex clinical trials, ensuring successful delivery in accordance with contractual commitments, SOPs, ICH-GCP guidelines, and applicable regulatory requirements. Qualified candidates will have 8+ years of clinical trial management experience, including prior experience within a CRO environment. Experience managing complex studies (such as respiratory or rare disease) and/or general medicine studies is required.  This is a permanent remote opportunity, with the potential for a hybrid work arrangement depending on location. Please note that you must have CRO experience to be considered.  Join our global team and help improve peoples' lives!   Main Job Tasks and Responsibilities: <ul> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Manage and coordinate the assigned clinical projects.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.).</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Knowledgeable in the application process for clinical studies, in force in the country/ies of work.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.).</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Assure the proper timelines of the assigned projects.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Manage the budget for the project.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Monitor the workload and the performance of the project team.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Plan and monitor the tasks of the team in the specific areas.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Coordinate the Clinical Research Associates and Clinical Monitors activity.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.).</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Collaborate with the CTAs in archiving activities.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Deliver project specific trainings.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Organize and participate in Monitor and Investigator Meetings.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Organize or take part in the periodic project update meetings.</s

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