Ipsen Group
Cookie Notice* 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.* 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).* 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%.* 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.* 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.* Bachelor’s degree in a relevant life sciences discipline, medical degree, or other equivalent qualifications.* Minimum: CRA graduated### Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. #J-18808-Ljbffr
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).* 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%.* 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.* 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.* Bachelor’s degree in a relevant life sciences discipline, medical degree, or other equivalent qualifications.* Minimum: CRA graduated### Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. #J-18808-Ljbffr