Senior Clinical Project Manager

Title:

Senior Clinical Project Manager

Company:

Ipsen Bioscience, Inc.

Job Description:

Senior Clinical Project Manager (SCPM)

Summary / purpose of the position

• Accountable for the clinical trial execution and management of all aspects of the assigned global international clinical study(ies) outsourced to a CRO in respect of planning/timelines, quality, budget, and defined goals.
• Drive execution and report study activities in conjunction with Clinical Development Program Directors (CDPDs), Medical Dev. Directors (MDDs), and other Ipsen team members.
• Endorse project plans developed by the CROs in accordance with study objectives and Ipsen requirements in terms of team responsibility, risk mitigation plan, escalation process, communication plan and track performance and quality aspect.
• Ensure the Global clinical studies are managed according to Good Clinical Practice (GCP), local regulations, guidelines, and SOPs in the required standard of quality.
• Accountable for the accuracy of the study budget and study information in all study databases and tracking systems.
• Accountable for ongoing and effective collaborations with internal and external stakeholders of the study: Lead, Manage and Drive the cross-functional Clinical Study Team and Contract Research Organization (CRO)/Service Providers in collaboration with the CDPDs and Ipsen team members responsible of the study.
• Lead innovation by identifying areas for process or technology improvements and participate in continuous improvement initiatives

Main responsibilities / job expectations

Responsibilities include, but are not limited to the following:

Ensure study team management and communication:

• Oversee and drive cross-functional leadership and expertise to ensure effective contribution, execution and delivery of study activities as per quality, plan/timelines and budget for one study or more within a clinical program
• As directed by Line manager, manage, coach and develop some Clinical Operation team members assigned to the study or program
• Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including Ipsen clinical study team members (TA, Biometry, Pharmacovigilance, Finance controlling, Global Regulatory Affairs, CMC Supply chain…) and CROs
• Establish and maintain excellent professional relationships with Services Providers / CROs, clinical study team through regular communication, between company, investigators and experts in conjunction with
• Medical Dev. Director (MDD) and other relevant Ipsen team members

Lead clinical project processes:

• Support the CDPD and collaborate closely to define study or program strategic direction and might represent the CDPD to project or asset team meetings, as needed
• Lead cross-functional clinical study teams focused on conduct of assigned projects
• Review and analyse status reports provided by Service Provider/CRO and highlight issues to facilitate decision making and escalate as required
• Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study feasibilityto CSR, in
• respect of GCPs, Regulatory requirements and relevant SOPs

Key accountabilities and activities:

• Set-up study team before Services Provider / CRO are on board and lead and manage regular internal Study Team meetings during the course of the study.
• Contribute to study protocol development including study concept where applicable
• Develop and control planning and study timelines in collaboration with all other Ipsen supportive functions/CRO
• Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider/CRO
• Participate in the selection of Services Providers /CROs and other external vendors in collaboration with purchasing department, study team and Corporate Legal Affairs
• Accountable for the development, management and tracking of trial budget working closely with the finances and service provider representative - financial management of the clinical trial including budget planning and preparation of quarterly reports
• Ensure appropriate oversight of Services Providers /CRO(s) and other external vendors activities and develop the oversight manual in accordance with the services providers Technical Specifications document