Local Clinical Project Manager (Oncology)

About the role

iQVIA is looking for a Local Clinical Project Manager (sponsor dedicated) in Athens to lead Local Study Teams at country level and deliver committed parts of clinical studies within agreed resources, budget and timelines, in line with Sponsor Procedural Documents, ICH-GCP and local regulations. The role may also include site monitoring under a flexible capacity model, and covers the full site lifecycle from identification and qualification to initiation, monitoring, closure and archiving.

Key responsibilities

• Lead the Local Study Team of CRAs and CSAs and ensure compliance with Sponsor procedures, ICH-GCP and local regulations.
• Ensure clinical and operational feasibility assessments of potential studies are done to the highest quality.
• Coordinate site selection, including site quality risk assessment and Site Qualification Visits.
• Ensure timely submission of applications to EC/IRB and coordination with Regulatory Affairs for regulatory submissions.
• Prepare the country financial Study Management Agreement, maintain the study budget, prepare the local Master CSA and amendments, and prepare the country-level Master Informed Consent Form and site-level ICFs, including translations.
• Collect all ICH-GCP trial documents before study start, plan local drug activities and set up the study in CTMS and local websites.
• Oversee monitoring from site activation to closure, review monitoring reports and advise monitors, and carry out co-monitoring and accompanied site visits.
• Identify risks, resolve complex study issues and organise regular Local Study Team meetings.

Required profile

• Bachelor's degree in a related discipline, preferably life sciences, or equivalent.
• At least one year of experience in local-level clinical project management.
• Very good knowledge of the oncology therapeutic area.
• Ability to lead and motivate cross-functional teams to deliver trials on time, within budget and to required quality.
• Excellent understanding of the clinical study process, including monitoring.
• Strong prioritisation, attention to detail and negotiation skills.
• Very good spoken and written Greek and English.
• Ability to travel nationally and internationally as required.
• Candidates must be based in the listed location (Athens); others will not be considered.

Required skills

• Project management
• ICH-GCP
• CTMS

The potential annualised base pay range is 49,500 to 74,200 EUR, depending on qualifications, location and schedule; incentives, bonuses and other benefits may also apply.