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) at Ipsen Bioscience, Inc. is responsible for coordinating clinical monitoring activities and overseeing the clinical and site management activities of Contract Research Organizations (CROs) for assigned international Phase 2/3 clinical studies. This role is crucial in ensuring that all activities are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and Standard Operating Procedures (SOPs). The CML will work to uphold the highest standards of quality, timely delivery, and budget adherence, thereby contributing to the overall Clinical Development objectives and achieving clinical excellence. In this position, the CML will coordinate the achievement of assigned clinical study deliverables within a matrix organization, working closely with Clinical Project Managers (CPMs) and acting as an Ipsen representative at clinical sites to build strong relationships with investigators. The CML will ensure efficient study start-up by overseeing the CRO clinical team and collaborating with other relevant team members involved in the study setup, including Data Management (DM), Regulatory (Reg), and Chemistry, Manufacturing, and Controls (CMC) teams. This includes reviewing site feasibility reports, supporting CPMs in site selection, and ensuring timely collection of essential study documents. The CML will also be responsible for training Clinical Research Associates (CRAs) on study-specific operational activities, preparing necessary documents for monitoring and reporting, and customizing Key Risk/Performance Indicator templates. The role involves co-monitoring clinical studies, ensuring adequate contact with investigator sites, and participating in ongoing clinical study data reviews. The CML will maintain and review key clinical documents required for Clinical Study Reports (CSRs) and assist in audit preparations and follow-ups. Additionally, the CML will contribute to the efficient operation of the Therapeutic Area (TA) Group and participate in various initiatives, including SOP updates and training material reviews. The position requires compliance with Environmental Health and Safety (EHS) regulations and participation in mandatory EHS training. Overall, the CML plays a pivotal role in ensuring the successful execution of clinical studies while adhering to Ipsen's global standards and regulations.

Responsibilities

• Coordinate clinical monitoring activities and oversee CRO clinical/site management activities for assigned international Phase 2/3 clinical studies.
• Ensure efficient study start-up by overseeing the Clinical team of the CROs and collaborating with relevant team members.
• Review site feasibility reports and support CPM in site selection.
• Verify timely collection of essential study documents for submission and ensure all setup activities are performed prior to site initiation.
• Support the Clinical CRO in training CRAs on study-specific operational activities.
• Assist CPM/study team in evaluating timelines and establishing clinical study milestones.
• Prepare and assist in producing documents necessary for clinical activity implementation, monitoring, and reporting.
• Customize site Key Risk/Performance Indicator template and monitor these indicators as per the oversight plan.
• Validate final clinical study documents prepared by the Clinical CRO.
• Review site visit reports and ensure timely follow-up of issues raised by monitors.
• Coordinate and manage the CRO relationship, assisting CRO CRAs/CTLs as necessary.
• Participate in the RFP process and BID defense meetings with CPM.
• Co-monitor clinical studies according to the oversight plan and ensure adequate contact with investigator sites.
• Participate in ongoing clinical study data reviews and ensure agreed timelines for data collection are met.
• Ensure study samples/assessments flow as required per protocol is well coordinated among stakeholders.
• Participate in TMF quality check reviews and ensure adequate completion during the study course.
• Maintain and review key clinical documents required for Clinical Study Report (CSR).
• Assist in audit preparations and follow-ups, and act as an Ipsen ambassador at site.

Requirements

• Minimum of CRA (Clinical Research Associate) graduate or relevant life science/medical qualifications.
• At least 1 year of experience as a Lead CRA, ideally 2 years, coordinating clinical activities/site management for international registrational studies.
• Minimum of 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.
• Previous experience in therapeutic areas such as Neuroscience, Oncology, or radiopharmaceutical compounds is a plus.
• Strong intermediate level of English.

Nice-to-haves

• Experience in therapeutic areas such as Neuroscience, Oncology, or radiopharmaceutical compounds.
• Basic financial knowledge to work with financial tracking tools.