Sr. Clinical Project Manager
Employment Type: Full-Time
Industry: Executive Management
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The Senior Clinical Project Manager (Senior CPM) is responsible for studies (Phase IV and Patient Registry) conducted for Ipsen-US Medical & Regulatory Affairs with respect to: planning, implementation, coordination, reporting, and overall resource definition.The Senior CPM ensures that clinical studies are completed according to the Protocol, Good Clinical Practice (GCP) guidelines and Ipsen's or the Contract Research Organization's (CRO) SOPs. The Senior CPM ensures timely delivery and budget adherence in order to assist in the delivery of US Medical & Regulatory Affairs objectives.
- Has overall responsibility for assigned Clinical Studies from an Operations perspective
- Responsible for the direct oversight of all outsourced providers, i.e. CROs, CRAs, central laboratories, Electronic Data Capture (EDC), etc.
- Responsible for organizing and delivering relevant Clinical Study training to other Clinical Operations / CRO staff
- Foster and develop a team approach to all activities associated with the implementation of clinical studies; the team includes CROs' Monitors/Clinical Research Associates (CRAs
- Establish and maintain excellent professional relationships between the company and external experts in conjunction with Project Physicians
- Lead the feasibility and site selection processes for the Medical Affairs Studies with the support of the Ipsen Medical Science Liaisons (MSL) and CROs
- Responsible for preparing detailed timelines and establishing clinical study milestones for assigned projects, ensuring they are performed according to the Protocol, Good Clinical Practice guidelines, and SOPs and further ensuring timely delivery and budget adherence
- Identify, in conjunction with the medical Therapy area, high quality investigators and study sites for the conduct of clinical registration studies
- Review and recommend amendments to the study protocols to ensure the study feasibility and to subsequently plan and organize work schedules
- Ensure, in conjunction with the Regulatory, Pharmacovigilance and Data Management Departments, that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related activities
- Participate in the selection of CROs and other external vendors and take responsibility for ensuring that CROs/vendors deliver in accordance with the specification, quality standard and timeframe set; manage CRO/CRA relationship as required
- Prepare and/or manage the production of all documents necessary to implement and monitor the study in a professional, high quality and timely manner
- As applicable, manage and train CRAs, co-monitor study, review and approve site visit reports, ensuring timely and appropriate follow up of issues raised by monitors; conduct site visits as required
- Ensure regular and timely liaison with appropriate Medical & Regulatory entities and provide regular and timely reports on all site performance changes including scope, schedules and resources; provide guidance and support to other clinical operations support staff so that the administration activity/CRA activities are carried out efficiently
- Ensure preparation of confidentiality agreements and site investigational contracts according to internal Ipsen guidelines and liaise with legal as appropriate
- Contribute proactively to the efficient operation of the Medical Affairs Group and to systems (eDC, CTMS) and processes being planned and implemented; participate in the training on and preparation, review, updating of SOP
- Participate in the preparation and review of clinical study reports as assigned
- Participate in the preparation and review of regulatory submission documents as needed, including IND/NDA submissions, and IND/NDA update and supplements
- Ensure the completeness of the Clinical Trial Management Systems
- Ensure all the tasks related to the IPSEN Electronic Data Capture (EDC) systems are completed including the training and regular support of all users including external Monitors and Site personnel
- Supervises and/or Performs User Acceptance Testing of the eCRF
- Prioritize and schedule all matters related to the clinical studies
- Chair internal and external meetings (i.e. CRA/investigator meetings) related to the clinical study as designated
- Supervise the schedule of work for Medical Affairs personnel and CROs within the company
Education / Certifications:
Bachelor's degree required, advanced degree preferred
- Substantial relevant experience of pharmaceutical drug development including project management of domestic and international clinical studies for at least 5 years (Pharma or CROs)
- Two or more years of experience managing Phase IV and / or Registry trials is preferred
- Experience with expanded access programs is a plus
- Excellent knowledge of Good Clinical Practice (GCP)/ICH regulations.
- Experience preparing clinical study documentation.
- Experience managing and developing relationships with Contract Research Organizations (CROs).
- Experience compiling and managing clinical study budgets
- An understanding of the drug development process and a good knowledge of the pharmaceutical industry
- Excellent knowledge of regulatory requirements (ICH, GCP, Legal constraints)
- Excellent Leadership skills and capability to work within a team as leader and team player
- Experience working with multidisciplinary groups (internal & external) and ability to work within a matrix environment
- Manage multiple Clinical and Medical Programs
- Excellent organizational and management skills
- Excellent verbal and written communication skills
- Strong proficiency with Microsoft software (Word, Excel, PowerPoint and Outlook)
- Excellent attention to detail, organizational and time management skills to prioritize and coordinate workload with minimal supervision
- Strong communication skills, verbal as well as written
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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