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About the Role

Ipsen Biopharmaceuticals Inc. is seeking a Clinical Project Manager to lead, manage, and drive cross-functional clinical study teams and Contract Research Organizations (CROs). This role is crucial for ensuring the effective execution, delivery, and closing of clinical studies in alignment with quality, timelines, and budget, while fostering strong professional relationships with all stakeholders.

Responsibilities

Oversee and drive cross-functional leadership 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.
Establish and maintain excellent professional relationships with Service Providers and clinical study team members through regular communication.
Lead cross-functional clinical study teams focused on the 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.
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.
Accountable for the development, management, and tracking of trial budget, working closely with 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 to identify and gain approval for high quality investigators and study sites.
Provide support and oversee the activities of the Clinical Trial Associate (CTA) for various administrative and reporting tasks.
Provide support and oversee the activities of the Clinical Monitoring Lead (CML) to ensure coordination of clinical, monitoring, and site management activities.
Develop and approve a recruitment strategy and communication tools to increase study awareness, patient recruitment, and retention.
Ensure through study team management that necessary regulatory, safety, and data evaluation requirements are met.
Participate in meetings lead by SP, review meeting minutes and ensure issues are proactively identified, communicated, and resolved.
Ensure timely and accurate completion of project milestones and study progress tools, and escalate deviations.
Travel as needed to observe and discuss projects, build positive working relationships, and maintain enthusiasm.
For activities not outsourced, ensure regular forecast update and bulk shipment.
Work with line functions and Quality Assurance to identify potential quality issues and coordinate CAPA implementation.
Assist Quality Assurance within inspections preparation as applicable.
Participate in the preparation, review of clinical study reports, and ensure CSR Appendices are completed and validated.
Liaise with relevant Ipsen or Service Providers teams to ensure the posting of the clinical study and the results on required registries.
Perform any other activity as may reasonably be required by the DCDP and/or TA clinical operation head.
Contribute/participate on SOP update and review training material.
Contribute to the efficient operation of the TA Group and to transversal projects.
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.

Requirements

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.
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.
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).

Skills

Fluent English
Leadership
Organizational skills
Management skills
Communication skills
GCP
ICH E6
EU Directive
Microsoft Office Suite
Financial tracking tools

Location

U.S.
France
U.K.

Work Type

Full-time

Experience Level

Minimum 3 years in clinical research
Minimum 2 years managing clinical activities for international registrational studies

Education Level

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

Salary/Compensations

$144,000 - $200,000

Benefits

401(k) with company contributions
Group medical, dental and vision coverage
Life and disability insurance
Short- and long-term disability insurance
Flexible spending accounts
Parental leave
Paid time off
Discretionary winter shutdown
Well-being allowance
Commuter benefits

About the Company

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.

Equal Opportunity

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.