Global Project Manager - Clinical Trials (Home-based)

Global Project Manager- location any UK - Flexible (Homebased)

DOCS has partnered with one of the world’s leading biopharma companies on a global study management initiative that has created exciting opportunities for professionals with clinical study management experience.

We are looking for talented and motivated candidates to join the team and take part in this long term, dynamic project. The project will provide exposure across a variety of Therapeutic Areas with an organization that is on the forefront of adopting new processes and technologies, creating a unique opportunity for career growth and development.

Critical to the project is the role of Global Project Manager. The Global Project Manager will be responsible for the planning and management of clinical studies conducted by Global Development through the leadership of the cross-functional Clinical Study Team (CST).

Key Responsibilities include:

• Leading and continually reviewing risk mitigation activities to ensure study delivery to plan

• Contributing to study-level risk assessments

• Identifying and resolving issues at a global level

• Reporting study progress at appropriate forums and to management

• Collaborating with Regional CTM to ensure country level study delivery aligned with global delivery plans

• Overseeing global insourcing/outsourcing partner deliverables to the required standards

• Managing study-level budget and timelines

• Partnering with Tech Services, Supplier Governance and Electronic Trial Operations - to ensure vendor set-up, conduct and quality oversight of deliverables

• Leading global study-level documentation and required tool and systems set-up

• Leading development and implementation of global Drug Supply Plan

• Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines

Critical Success Factors for the Role include:

• Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines

• Strong knowledge of Clinical Development process and procedures

• Project management experience including oversight of study deliverables, budgets, and timelines

• Ability to use scientific and clinical knowledge to conceptualize study designs

• Experience anticipating and resolving problems

• Experience writing and presenting clearly on scientific and clinical issues

• Experience collaborating and leading cross-functional teams (team/matrix environment)

• Knowledge of project risk management assessment and mitigation approaches

Requirements and Qualifications:

• BA/BS/BSc or RN

• Broad experience working in life sciences or medically related field

• General biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company

• Experience in oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.) highly preferred

Key Competencies:

Project Management / Risk Assessment / Critical Thinking and Planning / Matrix Team / Organizational Leadership / Metrics Analysis / Strong Written and Oral Communication / Delivery Focus / Decision Making / Relationship Management / Conflict Resolution / Problem Solving / Adaptability and Flexibility

Why Join DOCS?

If you are an experienced clinical professional looking for an opportunity with a rapidly growing and fast paced global leader on an interesting and complex project this would be a compelling role for you. To express your interest please reply to this role and a DOCS Recruitment specialist will contact you to discuss the position in detail.

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