Senior Clinical Monitoring Lead

Title:

Senior Clinical Monitoring Lead

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 Senior Clinical Monitoring Lead (Sr. CML) will serve as the lead CML for complex studies involving multiple Clinical Monitoring Leads, providing strategic oversight in alignment with the Clinical Project Manager and Clinical Program Director. This role includes mentoring and coaching other CMLs within the Clinical Development Operations (CDO) organization, as well as contributing to cross-functional initiatives and process improvements.

The Sr. CML is fully accountable for all clinical monitoring activities, including oversight of CRO clinical and site management operations, and co-monitoring assigned international Phase I to III clinical studies in accordance with GCP guidelines and applicable regulations. This role fosters strong relationships with investigators and proactively serves as a site engagement lead and Ipsen ambassador.

Operating within a matrix organization, the Sr. CML ensures the successful delivery of assigned clinical study milestones in close collaboration with the Clinical Project Manager, Clinical Program Director, or CML Lead, as applicable.

WHAT - Main Responsibilities & Technical Competencies

Clinical study set up, activities coordination & oversight responsibilities:

• Ensure efficient and thorough study feasibility, either directly if internally managed, or by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study feasibility (MDD, Reg, digital etc…): ensure feasibility assessment is appropriately managed, and reports are exhaustive. Prepare or Review site feasibility reports as per oversight plan, as applicable, to ensure appropriate strategy is in place for the country/site selection for the success of the study in collaboration with the CPM/Clinical Program Director and ensure validation of the study feasibility report by the TA CDO head.

• Ensure efficient and thorough study start-up, either directly if internally managed, or by overseeing the Clinical team of the CROs and working closely cross-functionally with other relevant team members involved in the study set up (DM, Reg, CMC etc…): Verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, oversee site Clinical Trial Agreements preparation and control that all set up activities are pro-actively managed and performed prior to each site initiation, as per the oversight plan.

• Ensure timely site contract negotiation and compliance of the site budget per agreed fair market value (FMV) at country level, including site overheads and patients’ stipends and compensation

• Contribute to establish the participant recruitment strategy to ensure materials are developed and submitted to IRBs/ECs (local/central advertising), contract with site include correct languages and adequate fees (referral network, participation to sponsor & sites calls)

• Support and ensure that all specific Ipsen/CRO EDC and/or eCOA system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial (Participate in the development of the eCRFs, eCOA, randomization and supplies workflow set up and participate in the UAT activities for all systems involved, as applicable)

• Responsible for reviewing the CRA training material and site facing materials (e.g. Protocol training, study manuals, vendor manuals etc) and coordinating the review of such documents to the other study team members as applicable (DM, CMC, MDD etc…). Validate the final clinical study documents (such as patient facing documents, study manual, monitoring plan …) prepared by the Clinical CRO, as per the oversight plan.

• Ensure CRO CRAs are appropriately trained to study protocol and support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)

• and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)

• Assist the CPM/ study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.

• Participate in the RFP process to review the assumptions going into monitoring activities.  Collaboration with the CPM in the RFP process and participation to BID defence meeting

• Participate to the preparation of the internal Oversight Plan and review/comment associated documents managed by the CRO that are necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan, data cleaning plan and clinical monitoring metrics…).

• Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan

• Ensure site initiation visits are occurring as planned.

• If applicable to set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations during start-up phase to discuss any potential sites we should consider for the study If assigned CML lead in a study, ensure task and delegation between CML team is in place and ensure oversight of the other CML activities

• As applicable collate/review the feedback/findings from all CMLs to provide a holistic overview for the CPM/study team and assess for trends

• Responsible for oversight and financial management of third-party vendors as agreed with CPM (i.e. IWRS, Central lab)

Site Relationships, Recruitment and Monitoring Oversight responsibilities:

• Be an IPSEN Ambassador at site: create and build relationship with our Investigators, by discussing patient pathways, recruitment challenges and any other study specific topics in a problem-solving mindset, for Ipsen to become their partner of choice.

• Ensure that regular meetings/calls are set up with the sites to help boost the recruitment and that high-enrolling sites are sharing experience/information with other sites.

• Perform clinical study monitoring oversight according to the oversight plan, ensuring adequate contact with investigator sites, identifying and solving issues in study progress, verifying data in-house or by conducting co- visits, in collaboration with other study team members, and following up as required with CROs/CRAs/investigator.  Co-monitor at site if required.

• Review all/ a sample of site visit reports as per the Oversight Monitoring Plan, ensuring timely and appropriate follow up of issues raised by monitors (Corporate & affiliates and/or CROs as appropriate) and look for trends or issues in the reports as per customized KRIs/KPIs of the oversight plan.

• If applicable, provide support and guidance to Internal CRAs (Ipsen Corporate & Affiliates with provision of some supervision in specific cases).

• Coordinate and manage the CRO relationship, assisting CRO CRAs/CTLs when and where necessary.

• Participate in the ongoing clinical study data reviews in collaboration with the other study team members. Work with CRO and Ipsen teams to ensure study tools (internal and external) are completed timely and accurately to provide correct reporting on study progress (study protocol approval, site initiation, participants recruitment and follow up, data entry cleaning, site closure…)

• Manage and oversee the allocation of the reviews within the CML team as applicable.

• In collaboration with the data transparency team, review and update CT.GOV details under the supervision of the CPM

• Ipsen get appropriate reporting of their status.

• Participate in TMF quality check review regularly to ensure adequate completion during the study course with a final thorough review at the end of the trial prior to study archiving

• Participate in the preparation and follow-up of any other study systems (such as IWRS/IMP forecasting/ flow etc…), as required.

• Maintain and review key clinical documents required for Clinical Study Report (CSR), to ensure adequate quality (e.g. for CSR appendices publishing)

• As appropriate, participate in the preparation of study documents and perform site visits prior to audits /inspection and assist in audit follow-up /findings resolution.

• Sr CML: Identify need for training refresh or training development for CRAs and site staff based on monitoring oversight outputs, work with CRO and Ipsen teams for creation and implementation

• Perform various study-related functions to ensure the execution of clinical studies such as:

• • act as site CRA as directed by line manager

  • act as back up of the CPM when requested

  • take on certain allocated CPM responsibilities (Sr CML).

Complete all of the above activities within the framework and in compliance with Ipsen Global SOPs and other documentation in force within the Ipsen Group.

 

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 …)

• Onboard and train new CMLs joining the company

• For company acquisitions or licensed assets, as requested, provide subject matter expertise in effective integration planning, implementation and monitoring of integration activities within the CDO integration team in collaboration with CDO integration Lead

EHS responsibilities:

• 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

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Minimum of 7 years’ experience in clinical research within a sponsor or CRO environment, including responsibilities preparing for clinical study documentation across study start-up, maintenance, and close-out, as well as management oversight of multi-country and multi-site studies.

• Excellent knowledge of Good Clinical Practices (GCP), ICH regulations, and any other applicable clinical study regulations.

• Strong Experience in managing and developing relationships with investigational sites and Contract Research Organizations (CROs).

• Demonstrated ability to train, mentor, and coach junior staff.

• Skilled in building and maintaining effective relationships with external stakeholders, including investigators, site staff, and patient association groups.

• Familiarity with Risk-Based Quality Management (RBQM), with specific experience in Risk-Based Monitoring (RBM).

• Travel Requirements: Domestic and international travel may be required. While the role is primarily office-based, travel is essential to effectively support the group and project needs. Estimated travel time averages between 25% and 40%.

Knowledge & Experience (preferred):

• Proven ability to operate effectively within a highly regulated environment within a Quality Management System (QMS).

• Advanced proficiency in software applications such as Microsoft Word, Excel, PowerPoint, and Adobe Reader.

• Exceptional organizational skills with a strong ability to manage priorities and meet deadlines.

• Collaborative mindset with the ability to contribute effectively within cross-functional and multidisciplinary teams.

• Travel Requirements: Domestic and international travel may be required. While the role is primarily office-based, travel is essential to effectively support the group and project needs. Estimated travel time averages between 25% and 40%.

• In-depth understanding of pharmaceutical industry R&D.

• Demonstrated commitment to continuous learning and performance improvement, with a focus on quality, timeliness, and cost-efficiency.

• Strong coordination, coaching, and interpersonal skills.

• Excellent verbal and written communication abilities.

• Professional integrity and awareness, with a pragmatic and hands-on approach to problem-solving.

• Proactive and adaptable, with a flexible approach to changing priorities and environments.

• Experience in aesthetics is strongly preferred.

 

Education / Certifications (essential):

• Bachelor’s degree in a relevant life sciences discipline, medical degree, or other equivalent qualifications.

• Minimum: CRA graduated

 

Language(s) (essential):

• Fluent in English.

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 $112,500-$165,000.

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.

#LI-Remote

#LI-MC1

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.