WHAT - Summary & Purpose of the Position
The Senior Clinical Project Manager is responsible for the execution and oversight of global clinical trials outsourced to CROs, ensuring alignment with timelines, quality standards, budgets, and study goals. This role collaborates closely with Clinical Development Program Directors (CDPDs), Medical Development Directors (MDDs), and other Ipsen team members to drive study activities and report progress. The manager endorses CRO-developed project plans, ensuring they meet Ipsen’s requirements for team responsibilities, risk mitigation, escalation processes, communication strategies, and performance and quality tracking. They also ensure that studies comply with Good Clinical Practice (GCP), local regulations, and internal SOPs.
In addition to managing study budgets and maintaining accurate data across tracking systems, the Senior Clinical Project Manager leads, manages, and drives the cross-functional Clinical Study Team and external partners, including CROs and service providers. The role fosters effective collaboration with all stakeholders to ensure high-quality execution. Furthermore, the manager contributes to innovation by identifying opportunities for process or technology improvements and actively participating in continuous improvement initiatives.
- 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 feasibility to 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
- Review final draft and approve major study documents as described in the Services Providers /CROs Technical Specification documents (e.g. oversight manual, communication plan, project plan, instruction manuals….)
- Supervise country feasibility and site selection processes in collaboration with CDPD, MDD, GMA, CRO and Ipsen Affiliates (if needed) to identify and gain approval for high quality investigators and study sites
- Provide support and oversee the activities of the Clinical Trial Assistant (CTA) assigned to the study for: insurance certificate, contracts signature process, set-up and management of the Trial Master File (eTMF), transparency and local reporting as per legal and Ipsen requirements, update of reporting tools (study trackers, Hermes, etc.) and alert if required; drive billing and forecast
- As applicable, provide support and oversee the activities of the Clinical Monitoring Lead (CL) to ensure the coordination of the clinical, monitoring and site management activities are in accordance with study objectives and quality standards.
- Work with the CRO, Patient Affairs office, and digital team as appropriate to develop and approve a recruitment strategy and communication tools (e.g. Newsletter…) to increase study awareness, patient recruitment and retention in the study
- Ensure through study team management that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related activities in conjunction with the Regulatory, Pharmacovigilance (GPS), Data Management and Statistics Departments
- Participate in meetings lead by CRO (e.g. Inv. & CRA meeting, Study team meeting, Clinical Data Review …), Review meeting minutes and ensure with CRO 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 (planning reporting, study dashboard…) and escalate appropriately in case of deviation to the planning and of any issue regarding the quality of the data
- Travel as needed to observe and discuss projects, build positive working relationships and maintain enthusiasm regarding projects
- For activities, not outsourced (e.g. Management of IMP…) 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 CRO
- Assist Quality Assurance (GDDQ) within inspections preparation as applicable
- Participate in the preparation and review of clinical study reports and ensure that CSR Appendices are completed and validated by the relevant functions within the agreed timelines.
- Liaise with the relevant Ipsen or Service Providers/CRO teams to ensure the posting of the clinical study and the results on the required registries and as per local regulations.
- To perform any other activity as may reasonably be required by the DCDP and/or TA clinical operation head from time to time.
- Clinical Activities (out of studies):
- Contribute/participate on SOP update and review training material as applicable
- Contribute to the efficient operation of the Clinical Development Operations department and to transversal project within Ipsen (e.g. systems implementation, change management initiatives, continuous improvement initiatives, etc.)
- EHS Responsibilities:
- Comply with applicable EHS regulations and procedures.
- Within its sphere of activity, to respect the regulations, to apply the IPSEN good practices and standards, and the EHS procedures set up on the site
- Participate in the EHS training as proposed or requested on the site Contribute to reduce the environmental impact of the activities on the site Inform his / her superiors of any changes affecting the workstation, in order to improve the EHS on site.
HOW - KNOWLEDGE & EXPERIENCE
Knowledge & Experience (essential):
- 10+ years working in clinical research with management of clinical activities for the set up and running of international registrational studies, for at least 8 years.
- Relevant experience of pharmaceutical drug development.
- 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.
- Ability to work in a strong regulated environment within a quality management system (QMS)
- Advanced proficiency in digital tools and software applications including Microsoft Office, Adobe Reader, etc.
- Proven leadership and collaboration skills, with the ability to work effectively in multidisciplinary teams.
- Basic Financial Knowledge- must be able to work with financial tracking tools.
- Knowledge of Pharmaceutical Industry R&D
- Strong understanding of FDA, EMEA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- 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)
- Strong organizational and management skills, with the ability to delegate effectively, and set and prioritize tasks.
- Demonstrate flexible and creative leadership and able to build a network.
- Strong verbal and written communication skills (English) with the ability to communicate effectively at different levels of the organization.
- Experience in outlining clinical study operational strategies and managing de-centralized studies.
- Experience with risk-based quality management (RBQM).
Knowledge & Experience (preferred):
- Aesthetics Experience strongly preferred.
Education / Certifications (essential):
- Bachelor’s degree in a relevant life sciences discipline is required.
Education / Certifications (preferred):
- Medical degree or equivalent advanced qualification(s) is preferred.
Language(s) (essential):
Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.
Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.
All Employees are expected to adhere to all company policies and act as a role model for company values.
The annual base salary range for this position is $143,250-$210,100.
This job is eligible to participate in our short-term incentives program.
At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills
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