Ipsen
Overview
Clinical Monitoring Lead
at
Ipsen
– Join to apply for this role. As Clinical Monitoring Lead, you will coordinate clinical monitoring activities across assigned international Phase studies, overseeing CRO clinical and site management activities, conducting co-monitoring visits, and ensuring all activities comply with regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal SOPs. Your focus is on timely delivery and budget adherence to support Clinical Development objectives and uphold high standards of clinical excellence. You will work within a matrix organization under the leadership of Clinical Project Managers (CPMs) and represent Ipsen at clinical sites, building relationships with investigators and fostering site engagement throughout the study lifecycle. Responsibilities & Technical Competencies
Coordinate and oversee clinical activities across studies, including start-up oversight of the CRO Clinical team and collaboration with study setup teams (DM, Reg, CMC, etc.) to ensure feasibility reports are exhaustive, site feasibility is reviewed, site selection supported, and essential regulatory/ethics documents are submitted in a timely manner. Ensure Ipsen/CRO EDC system tasks are completed within defined timelines without jeopardizing trial start. Train and guide CRAs on study-specific operations and participate in monitor and investigator meeting organization with study team members (Corporate and/or affiliates, CROs as appropriate). Assist CPM/study team in evaluating timelines and milestones, ensuring high-quality and timely delivery. Prepare/assist in documentation to oversee clinical activity implementation, monitoring and reporting (e.g., monitoring oversight plan, clinical monitoring metrics). Customize and monitor KRIs/KPIs as per the oversight plan. Validate final study documents (e.g., study manual, monitoring plan) prepared by the Clinical CRO. Review site visit reports and ensure timely follow-up of issues with monitors (Corporate & Affiliates and/or CROs). Provide guidance to Internal CRAs where applicable and coordinate CRO relationships, assisting CRO CRAs/CTLs as needed. Collaborate with CPM on RFP processes and participate in BID defense meetings; set up regular meetings with Local Medical Affairs (MSL at LMA) when applicable. Collaborate on study activities beyond core monitoring as required. Monitoring Oversight Activities
Participate in ongoing clinical study data reviews with the study team. Record and report data in CTMS with focus on quality and accuracy. Ensure timely data collection (CRF/eCRF) and resolution of data clarifications with data management and monitoring CROs. Coordinate flow of study samples/assessments between CROs, Ipsen departments, and central facilities per the protocol. Contribute to TMF quality checks and ensure thorough review at study end prior to archiving. Assist in preparation of systems (IWRS/IMP forecasting, etc.) as required and maintain CSR documentation quality. Participate in audit preparations and follow-up as appropriate; act as Ipsen ambassador at sites and build investigator relationships. Perform additional study-related functions to ensure successful execution, including acting as site CRA or backup CPM when requested. Clinical Activities (Out Of Studies)
Contribute to SOP updates and training materials created by Process Training Management. Support efficient operation of the TA Group and transversal projects across Ipsen (systems implementation, change management, continuous improvement). Provide subject matter expertise for acquisitions or licensed assets in integration planning and monitoring with the CDO integration team as needed. Comply with EHS regulations and participate in EHS activities and mandatory training. Complete all activities in compliance with Ipsen Global SOPs and applicable documentation. Knowledge & Experience (essential)
8+ years’ experience in pharmaceutical drug development with significant involvement in clinical research roles. Minimum 1 year (ideally 2) as Lead CRA coordinating clinical/site management for international registrational studies. At least 3 years’ experience as a Field CRA monitor (CROs or Pharma). Experience managing relationships with CROs and preparing clinical study documentation for setup, maintenance, and close-out. Experience working on global studies (multiple countries/sites). Excellent knowledge of GCP, ICH regulations, and other clinical study regulations. Knowledge of R&D and ability to work in a regulated environment within a QMS. Advanced proficiency with software (Word, Excel, PowerPoint, Adobe Reader) with basic financial tracking knowledge. Strong organizational, coordination, interpersonal, and coaching skills; ability to manage multiple tasks and deadlines. Excellent verbal and written communication; ability to work in a matrix, multidisciplinary environment; professional integrity and proactive attitude. Commitment to continuous learning and quality improvement. Knowledge & Experience (preferred)
Commitment to continuous learning and improvement in quality, timeliness, and cost-effectiveness. Education / Certifications (essential)
Degree in life sciences, medicine, or other relevant field. Clinical Research Associate (CRA) qualification (minimum requirement). 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, national origin, age, gender, sexual orientation, marital status, disability, genetic information, or any other protected category. Background screening, reference checks, and drug testing may be part of pre-employment screening. This description is not exhaustive and duties may change. All employees are expected to adhere to company policies and values. The base salary range is $112,500-$165,000, with eligibility for incentives. Ipsen offers a comprehensive benefits package including 401(k) with company contributions, medical/dental/vision, life and disability insurance, and other applicable programs. Note:
The job postings below show related roles and location snapshots and are not part of this job description.
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Clinical Monitoring Lead
at
Ipsen
– Join to apply for this role. As Clinical Monitoring Lead, you will coordinate clinical monitoring activities across assigned international Phase studies, overseeing CRO clinical and site management activities, conducting co-monitoring visits, and ensuring all activities comply with regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal SOPs. Your focus is on timely delivery and budget adherence to support Clinical Development objectives and uphold high standards of clinical excellence. You will work within a matrix organization under the leadership of Clinical Project Managers (CPMs) and represent Ipsen at clinical sites, building relationships with investigators and fostering site engagement throughout the study lifecycle. Responsibilities & Technical Competencies
Coordinate and oversee clinical activities across studies, including start-up oversight of the CRO Clinical team and collaboration with study setup teams (DM, Reg, CMC, etc.) to ensure feasibility reports are exhaustive, site feasibility is reviewed, site selection supported, and essential regulatory/ethics documents are submitted in a timely manner. Ensure Ipsen/CRO EDC system tasks are completed within defined timelines without jeopardizing trial start. Train and guide CRAs on study-specific operations and participate in monitor and investigator meeting organization with study team members (Corporate and/or affiliates, CROs as appropriate). Assist CPM/study team in evaluating timelines and milestones, ensuring high-quality and timely delivery. Prepare/assist in documentation to oversee clinical activity implementation, monitoring and reporting (e.g., monitoring oversight plan, clinical monitoring metrics). Customize and monitor KRIs/KPIs as per the oversight plan. Validate final study documents (e.g., study manual, monitoring plan) prepared by the Clinical CRO. Review site visit reports and ensure timely follow-up of issues with monitors (Corporate & Affiliates and/or CROs). Provide guidance to Internal CRAs where applicable and coordinate CRO relationships, assisting CRO CRAs/CTLs as needed. Collaborate with CPM on RFP processes and participate in BID defense meetings; set up regular meetings with Local Medical Affairs (MSL at LMA) when applicable. Collaborate on study activities beyond core monitoring as required. Monitoring Oversight Activities
Participate in ongoing clinical study data reviews with the study team. Record and report data in CTMS with focus on quality and accuracy. Ensure timely data collection (CRF/eCRF) and resolution of data clarifications with data management and monitoring CROs. Coordinate flow of study samples/assessments between CROs, Ipsen departments, and central facilities per the protocol. Contribute to TMF quality checks and ensure thorough review at study end prior to archiving. Assist in preparation of systems (IWRS/IMP forecasting, etc.) as required and maintain CSR documentation quality. Participate in audit preparations and follow-up as appropriate; act as Ipsen ambassador at sites and build investigator relationships. Perform additional study-related functions to ensure successful execution, including acting as site CRA or backup CPM when requested. Clinical Activities (Out Of Studies)
Contribute to SOP updates and training materials created by Process Training Management. Support efficient operation of the TA Group and transversal projects across Ipsen (systems implementation, change management, continuous improvement). Provide subject matter expertise for acquisitions or licensed assets in integration planning and monitoring with the CDO integration team as needed. Comply with EHS regulations and participate in EHS activities and mandatory training. Complete all activities in compliance with Ipsen Global SOPs and applicable documentation. Knowledge & Experience (essential)
8+ years’ experience in pharmaceutical drug development with significant involvement in clinical research roles. Minimum 1 year (ideally 2) as Lead CRA coordinating clinical/site management for international registrational studies. At least 3 years’ experience as a Field CRA monitor (CROs or Pharma). Experience managing relationships with CROs and preparing clinical study documentation for setup, maintenance, and close-out. Experience working on global studies (multiple countries/sites). Excellent knowledge of GCP, ICH regulations, and other clinical study regulations. Knowledge of R&D and ability to work in a regulated environment within a QMS. Advanced proficiency with software (Word, Excel, PowerPoint, Adobe Reader) with basic financial tracking knowledge. Strong organizational, coordination, interpersonal, and coaching skills; ability to manage multiple tasks and deadlines. Excellent verbal and written communication; ability to work in a matrix, multidisciplinary environment; professional integrity and proactive attitude. Commitment to continuous learning and quality improvement. Knowledge & Experience (preferred)
Commitment to continuous learning and improvement in quality, timeliness, and cost-effectiveness. Education / Certifications (essential)
Degree in life sciences, medicine, or other relevant field. Clinical Research Associate (CRA) qualification (minimum requirement). 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, national origin, age, gender, sexual orientation, marital status, disability, genetic information, or any other protected category. Background screening, reference checks, and drug testing may be part of pre-employment screening. This description is not exhaustive and duties may change. All employees are expected to adhere to company policies and values. The base salary range is $112,500-$165,000, with eligibility for incentives. Ipsen offers a comprehensive benefits package including 401(k) with company contributions, medical/dental/vision, life and disability insurance, and other applicable programs. Note:
The job postings below show related roles and location snapshots and are not part of this job description.
#J-18808-Ljbffr