Clinical Trial Manager - Sponsor Dedicated

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Clinical Trial Manager - Sponsor Dedicated, Milan

Client: IQVIA

Location: Milan

Job Category: Other

EU work permit required: Yes

Job Reference: 88afec2ca527

Job Views: 8

Posted: 19.02.2025

Expiry Date: 05.04.2025

Job Description:

Clinical Trial Management and Central Trial Oversight services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones, including country & site feasibility and site selection, trial set-up, trial execution and trial closure and vendor set up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL). This service supports the GTL in leading related CRO, country, and site activities, including global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners. Interface with stakeholders; internal and external to Global Clinical Development Operations (GCDO) functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, CRO staff, vendor staff and trial sites (if applicable). Work closely with the GCDO Trial Leader (GTL) and is member of the Trial Team, led by the GTL. Ensure inspection readiness through compliance with the clinical research protocol, company Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through close-out. Takes ownership for assigned responsibilities. Demonstrated competency to act as a backup or first point of contact in absence of the GCDO Trial Leader. Advanced is given assignments that are more complex and/or have a greater potential impact on business results. May act as the lead over a team of CTMs across a project/program, on insourced and outsourced studies. Able to lead taskforces and provide innovative input. May contribute to process improvement and/or non-project work.

Key Responsibilities:

1. Services rendered will adhere to applicable to sponsor´s SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
2. Lead the Study Management Team including providing updates to all trial team members on deliverable status.
3. Manage timely and accurate documentation and communication of trial progress.
4. Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
5. Act as primary contact for Country and Regional staff.
6. Partner with the Global Trial Lead to execute and oversee central activities from planning, trial start up, through the life of trial to close-out.
7. Ensure issue escalation and drive issue resolution.
8. Contribute to data collection to support the site selection process.
9. Establish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level.
10. Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level.
11. Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes.

Requirements:

1. BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
2. 6-8 years clinical trial management experience in the pharmaceutical industry or CRO.
3. Strong working knowledge of ICH-GCP, local laws and regulations.
4. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
5. Effective leadership skills and ability to manage multiple stakeholders.
6. Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.