Ref #: 28195

Employment type: Permanent - Full-Time

Location: US-MD-Gaithersburg

Posted: 02-Apr-2021


As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

At ICON DOCS, we have an incredible opportunity for an expert Global Clinical Project Manager to join the team in the US. Multiple positions available for home-based Global Clinical Project Managers in the US.

Global Clinical Project Managers for Late Phase Research, will lead and support the operational planning, delivery, oversight and budget management of company and/or externally sponsored research. They may also help coordinate the efforts of extended team members, notably the scientific study leader (epidemiologist for observational studies, Medical Affairs Leader for interventional studies). The Global Clinical Project Manager may own specific areas or deliverables within a study, or in some cases, assume the accountabilities of a team leader for study delivery.

In addition, the Global Clinical Project Manager will support Medical Evidence and Observational Research in continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials.

Key accountabilities of the Global Clinical Project Manager:
• Project Management of owned study areas to deliver according to cost, time and quality
• Develop and maintain the overall study budget (internal and external study costs)
• Support of study related to Risk Management and Quality Management activities
• Manage and reconcile Contracts, POs and invoices
• Support financial audit readiness and SOX attestation as needed
• Management of Study Governance processes
• Management of internal and external stakeholders
• Finance Management support

What you will need:
• Bachelor’s degree required, preferably in medical or biological science or equivalent by experience
• 3 years of cross-functional Global Project Management experience in multi-national, multi-site studies for Global Clinical or Medical Affairs Clinical Research Studies
• Oncology experience is required
• 7 years of Pharmaceutical experience
• 1 year of Vendor Management experience
• Medical Evidence generation experience is a plus
• Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.