The posting
Title:
Clinical Project Manager
Company:
Ipsen Biopharmaceuticals Inc.
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
Job Description:
WHAT - Summary & Purpose of the Position
The Clinical Project Manager is responsible for the planning, execution, and day to day management of global clinical studies outsourced to Contract Research Organizations (CROs), ensuring delivery against study timelines, quality expectations, budgets, and defined objectives. Working closely with Clinical Development Program Directors (CDPDs), Medical Development Directors (MDDs), CRO partners, and cross functional Ipsen teams, this role coordinates study activities, monitors progress and facilitates effective communication among stakeholders. The Clinical Project Manager reviews and supports CRO developed project plans to ensure alignment with study objectives and Ipsen requirements, including team responsibilities, risk management, escalation pathways, and communication strategies, while ensuring compliance with Good Clinical Practice (GCP), applicable regulations, guidelines, and internal standard operating procedures.
In partnership with the Clinical Study Team and external vendors, the Clinical Project Manager drives study execution, proactively identifies and resolves operational challenges, tracks project milestones and budgets, and supports timely delivery of study objectives. The role fosters collaboration across internal and external stakeholders to ensure studies are conducted efficiently, consistently, and to the required quality standards.
WHAT - Main Responsibilities & Technical Competencies
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.
- 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 SPs.
- Establish and maintain excellent professional relationships with Services Providers, 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:
- 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.
Key accountabilities and activities:
- Develop, manage, and execute assigned projects by:
- 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 - financial management of the clinical trial including budget planning and preparation of quarterly reports.
- Ensure appropriate oversight of Services Providers) 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 Associate (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 (CML) to ensure the coordination of the clinical, monitoring and site management activities are in accordance with study objectives and quality standards.
- Work with the SP, 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 SP (e.g. Inv. & CRA meeting, Study team meeting, Clinical Data Review …), 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 (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 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 by the relevant functions within the agreed timelines.
- Liaise with the relevant Ipsen or Service Providers 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 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 (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 superiors of any changes affecting the workstation, in order to improve the EHS on site.
HOW - Knowledge & Experience
Knowledge & Experience (essential):
- 8+ years of experience in clinical research with a Bachelor's degree, or 5+ years with an advanced degree (Master's, PharmD, PhD, MD, or equivalent), including at least 5 years managing clinical activities for the start up, execution, and oversight of international registrational studies.
- Relevant experience in pharmaceutical drug development and clinical study execution.
- Experience working effectively with and managing interactions 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.
- Strong 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
- Good 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
- Strong knowledge of regulatory requirement (ICH, E6, GCP, EU Directive)
- Strong organizational and management skills, with the ability to set and prioritize tasks effectively.
- Demonstrate flexibility, creativity, and the ability to build effective working relationships.
- 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 plans and managing de-centralized studies.
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):
- Fluent in English.
Compensation
The annual base salary range for this position is $144,000 - $200,000.
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.
This job is eligible to participate in our incentive compensation program as well as our long-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.
We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
