Clinical Project Manager

Responsibilities

• 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.
• Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including Ipsen clinical study team members and SPs.
• Establish and maintain excellent professional relationships with Services Providers, clinical study team through regular communication, between company, investigators, and experts.
• Lead cross-functional clinical study teams focused on conduct of assigned projects.
• Interact with CDPD to define strategic operational direction.
• Review status reports provided by Service Provider/CRO and highlight issues to facilitate decision making.
• Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study start-up to CSR, in respect of GCPs and relevant SOPs.
• Set-up study team before Services Provider 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/SPs.
• Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider.
• Participate in the selection of Services Providers and other external vendors in collaboration with purchasing department, study team, finance controller and Corporate Legal Affairs.
• Accountable for the development, management and tracking of trial budget working closely with the finances and service provider representative.
• Ensure appropriate oversight of Services Providers and other external vendors activities and develop the oversight manual.
• Review final draft and approve major study documents as described in the Services Providers/CROs Technical Specification documents.
• Supervise country feasibility and site selection processes in collaboration with CDPD, MDD, GMA, CRO and Ipsen Affiliates.
• Provide support and oversee the activities of the Clinical Trial Associate (CTA) assigned to the study.
• Provide support and oversee the activities of the Clinical Monitoring Lead (CML) to ensure the coordination of the clinical, monitoring and site management activities.
• Work with the SP, Patient Affairs office, and digital team to develop and approve a recruitment strategy and communication tools.
• Ensure through study team management that the necessary regulatory, safety and data evaluation requirements are met.
• Participate in meetings lead by SP, review meeting minutes and ensure with SP Project Manager that issues are proactively identified, communicated and resolved in a timely manner.
• Ensure timely and accurate completion of project milestones, study progress tools and escalate appropriately in case of deviation.
• Travel as needed to observe and discuss projects, build positive working relationships, and maintain enthusiasm regarding projects.
• For activities not outsourced, ensure regular forecast update and bulk shipment.
• Work with line functions and Quality Assurance (GRDQ) to identify potential quality issues.
• Coordinate post quality audit hosted by Sponsor and ensure CAPA implementation by SP.
• Assist Quality Assurance (GDDQ) within inspections preparation as applicable.
• Participate in the preparation, review of clinical study reports, and ensure that CSR Appendices are completed and validated.
• Liaise with the relevant Ipsen or Service Providers teams to ensure the posting of the clinical study and the results on the required registries.
• Contribute/participate on SOP update and review training material created by Process Training Management.
• Contribute to the efficient operation of the TA Group and to transversal project cross-TAs and other departments within Ipsen.
• Comply with applicable EHS regulations and procedures.
• Participate in the site's EHS performance by reporting risks, malfunctions, or improvements.
• Participate in mandatory EHS training.

Education / Certifications

Bachelor's degree in life science or medical graduate preferred, or relevant qualifications.

Experience

• Relevant experience of pharmaceutical drug development: Minimum of 3 years working in clinical research with management of clinical activities for the set up and running of international registrational studies, for at least 2 years.
• Experience in managing and developing relationships with Contract Research Organizations (CROs/SPs).
• Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability, and ability skills to work within a matrix environment.
• Fluent English.
• Ability to work in a strong regulated environment within a quality management system (QMS).
• Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader).
• Ability to organize and prioritize.
• Able to produce work in teams and within a multi-disciplinary environment.
• Basic Financial Knowledge - must be able to work with financial tracking tools.
• Knowledge of Pharmaceutical Industry R&D.
• Good understanding of the drug development process and knowledge of the pharmaceutical industry environment.
• Good knowledge of the Good Clinical Practices (GCP) or other clinical study regulations.
• Intimate knowledge of regulatory requirement (ICH E6, GCP, EU Directive).
• Excellent leadership skills and capability to work within a team as leader and team player.
• Excellent organizational and management skills.
• Strong verbal and written communication skills (English).