Clinical Monitoring Lead

$112,500 - $165,000/Yr

Ipsen Bioscience

Full-time - Mid Level

Professional, Scientific, and Technical Services

About the position

The Clinical Monitoring Lead (CML) is responsible for coordinating clinical monitoring activities and overseeing the CRO clinical/site management activities for international Phase 2/3 clinical studies. This role ensures compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines, aiming for high-quality delivery within budget and timelines. The CML acts as a representative of Ipsen at clinical sites, fostering relationships with investigators and ensuring the successful execution of clinical studies.

Responsibilities

• Coordinate clinical activities and oversight for assigned studies.
• Ensure efficient study start-up by overseeing CRO clinical teams and collaborating with relevant team members.
• Support the Clinical CRO in training CRAs on study-specific operational activities.
• Assist in evaluating timelines and establishing milestones for clinical studies.
• Prepare and assist in producing documents necessary for clinical activity monitoring and reporting.
• Customize and monitor Key Risk/Performance Indicators (KRIs/KPIs) as per the oversight plan.
• Validate final clinical study documents prepared by the Clinical CRO.
• Review site visit reports and ensure timely follow-up on issues raised by monitors.
• Coordinate and manage the relationship with CROs, assisting CRAs/CTLs as necessary.
• Participate in the RFP process and BID defense meetings with CPM.
• Co-monitor clinical studies according to the oversight plan, ensuring adequate contact with investigator sites.
• Participate in ongoing clinical study data reviews and ensure timelines for data collection are met.
• Ensure proper coordination of study samples and assessments as per protocol.
• Participate in TMF quality checks and ensure completion during the study course.
• Assist in preparing for audits/inspections and follow-up on findings resolution.

Requirements

• Minimum CRA graduate with a life science or medical degree.
• At least 1 year of experience as a Lead CRA, ideally 2 years, coordinating clinical activities for international studies.
• Minimum 3 years of experience as a Field CRA monitor in CROs or the pharmaceutical industry.
• Excellent knowledge of Good Clinical Practice (GCP) and ICH regulations.
• Experience in preparing clinical study documentation for setup, maintenance, and closing.
• Experience in managing relationships with Contract Research Organizations (CROs).
• Experience in global studies across multiple countries/sites.

Nice-to-haves

• Previous experience in therapeutic areas such as Neuroscience, Oncology, or radiopharmaceutical compounds is a plus.
• Strong intermediate level of English.

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