Clinical Monitoring Manager (CMM)

$171,900 - $210,100/Yr

Ipsen Bioscience - Cambridge, MA

Full-time - Manager

Cambridge, MA

Professional, Scientific, and Technical Services

About the position

The Clinical Monitoring Manager (CMM) at Ipsen Bioscience, Inc. is responsible for leading and developing a team of Clinical Monitoring Leads (CMLs) and Senior CMLs. This role involves training team members, managing site relationships, and contributing to recruitment efforts. The CMM oversees clinical monitoring activities for global Phase 1 to 3 clinical studies, ensuring compliance with Good Clinical Practice (GCP) guidelines and regulations. The position requires strong collaboration with Clinical Project Directors (CPDs) and involves significant oversight of clinical study deliverables within a matrix organization.

Responsibilities

• Lead and develop a team of Clinical Monitoring Leads (CMLs) and Senior CMLs.
• Train team members on clinical monitoring lead responsibilities and study protocols.
• Manage site relationships and act as an Ipsen Ambassador.
• Coordinate achievement of clinical study deliverables in collaboration with CPDs.
• Oversee CRO clinical/site management activities in accordance with GCP guidelines.
• Develop KPIs, metrics, and dashboards to monitor team performance.
• Conduct co-visits with team members to assess development and training needs.
• Ensure efficient study feasibility assessments and site selection processes.
• Manage study start-up activities and ensure timely collection of essential documents.
• Support participant recruitment strategies and ensure compliance with site budgets.
• Review and validate clinical study documents prepared by CROs.
• Participate in the RFP process and assist in bid defense meetings.
• Monitor clinical study progress and ensure timely reporting of findings.

Requirements

• Minimum 10 to 12 years of experience as a CML/Sr. CML in Pharma, Biotech, or CRO.
• At least 2 years of experience in people management, managing and/or coaching CRAs.
• Strong knowledge of Good Clinical Practice (GCP) and ICH regulations.
• Experience in preparing clinical study documentation for study set up, maintenance, and closing.
• Experience managing relationships with CROs and vendors.
• Global studies experience across multiple countries/sites.
• Life science or medical graduate or other relevant qualifications.

Nice-to-haves

• Experience in the therapeutic area of studies such as Neuroscience, Oncology, or radiopharmaceutical compounds.
• Strong intermediate level of English proficiency.

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