Full-Time Global Clinical Project Manager

We currently have an exciting new opportunity for an experienced Global Clinical Project Manager within the Early Hematology team to join a successful sponsor dedicated program.

We are looking for a Global Clinical Project Manager which is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the project delivery of clinical studies.

The Global Clinical Project Manager is responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery.

The Global Clinical Project Manager is the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving.

The Global Clinical Project Manager is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget, and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

The Global Clinical Project Manager leads the study team and/or study oversight team in accordance with the study team operating model, current clinical trial regulations (e.g. ICH GCP).

Responsibilities:

• Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards.
• Lead and facilitate communication across all functions, including external partners and service providers.
• Provide input into and hold accountability for the development of essential study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs.
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs.
• Responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans.

Qualifications:

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
• 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ Global project management experience, or equivalent
• Extensive knowledge of ICH-GCP, clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development
• Strong, demonstrated abilities/skills in team leadership
• Excellent communication and interpersonal skills

You must have current experience working in the clinical research industry within a Pharma or CRO setting within Global study delivery.

You must have the right to work with no sponsorship requirements in the following countries: Spain, Poland, Bulgaria.

What is the last date for applying to the job?

Which countries are accepted for this remote job?