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Ipsen · 7 hours ago

Senior Clinical Project Manager

Cambridge, MA

Full-time

Onsite

Senior Level, Lead/Staff

$143K/yr - $210K/yr

10+ years exp

Ipsen is a biopharmaceutical company that focuses on innovative medicines. The Senior Clinical Project Manager is responsible for the execution and oversight of global clinical trials, collaborating with various stakeholders to ensure alignment with timelines and quality standards.

BiotechnologyPharmaceuticalProduct Research

H1B Sponsor Likely

Responsibilities

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

Qualification

Clinical trial managementClinical Practice (GCP)Pharmaceutical drug developmentLeadership skillsFinancial managementRegulatory knowledgeDigital tools proficiencyMultidisciplinary collaborationRisk managementCreative leadershipEnglish fluencyCommunication skillsOrganizational skillsAdaptabilityTeam management

Required

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)

Bachelor's degree in a relevant life sciences discipline is required

Fluent in English

Preferred

Aesthetics Experience strongly preferred

Medical degree or equivalent advanced qualification(s) is preferred

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

Company

Ipsen

Glassdoor3.7

Ipsen is a global specialty-driven biopharmaceutical company focused on innovation and specialty care.

Founded in 1929

Boulogne-billancourt, Ile-de-France, FRA

5001-10000 employees

http://www.ipsen.com

H1B Sponsorship

Ipsen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2020 (1)