Local Clinical Project Manager - Oncology

About the role

The Local Clinical Project Manager (sponsor dedicated) leads Local Study Teams at country level to deliver committed components 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 of documentation.

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 and documents to EC/IRB and to regulatory authorities, working with Regulatory Affairs.
• 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 required before study start and set up the study in CTMS and local websites.
• Plan and coordinate 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 clinical project management at local level.
• 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 the required quality.
• Excellent understanding of the clinical study process, including monitoring; strong project management, prioritisation, attention to detail and negotiation skills.
• Very good spoken and written English; ability to learn and adapt to IT systems; willingness to travel nationally and internationally.
• Candidates must be based in the listed location; applications from elsewhere will not be considered.