Project Manager - Clinical Development

CK Group is currently seeking a Project Manager to work remotely across the USA within the clinical development department of a leading full service CRO. This is a permanent position based remotely within the USA with a requirement for travel.Responsibilities (include, but not limited to):

• Act as the primary point-of-contact and liaison with the Sponsor to provide outstanding customer service and serve as an ambassador to promote our clients high quality and ethical image.
• Leads and manages the cross-functional project team, which includes Clinical, Regulatory, Data Management, Biostatistics, Medical, Pharmacovigilance, Technical Writing, Laboratory, IMP Management and Contracts.
• Lead the CRA team on smaller studies where no Clinical Trial Lead has been assigned.
• Manage contractual project deliverables, such as agreed timelines, quality/scope, and cost, including monitoring progress via metrics.
• Develop appropriate study management plans in collaboration with service leads.
• Manage Risk associated with Project and resolve issues with appropriate support from a Senior Project Manager, Associate Project Director or Project Director.
• Manage vendors who provide services in support of the projects. This includes identification of the vendors, obtaining quotes for the scope of their work and managing this work as per the agreed contract with appropriate support from a Senior Project Manager, Associate Project Director or Project Director.

Required qualifications:

• Degree or equivalent level qualification in life sciences / related area or equivalent combination of education, training and experience.
• Experience of managing Clinical Projects with a minimum of 2 services within a Clinical Research Organisation (CRO) or pharmaceutical industry.
• Experience of managing Phase 1- III patient studies as a PM or extensive experience in supporting such studies as an Associate PM.
• In-depth knowledge of, and skill in applying ICH-GCP guidelines and any other applicable clinical research regulatory requirements.
• Experience with using tools such as eTMF and CTMS.

Apply: Entitlement to work in the USA is essential. Please quote job reference 53406 in all correspondence.