Description CST Project Manager (eCOA Manager) ** Remote several EMEA countries **
Job Responsibilities Job Summary; Provides customer-focused management of Clinical Surveillance & Training (CST) scoped services to support scientific integrity and data quality in clinical trials.
Duties also include liaising with customers, vendors and/or investigative sites to manage projects start-up to final deliverables to the customer. Upon displaying proficiency, a CST Project Manager II may be awarded the opportunity to function at the CST Sr. Project Manager level.
Core Responsibilities; • Working under the limited guidance and mentorship of the CST Director BU Ops, Management (Line Manager) or designee:
- Function as a representative of the Clinical Surveillance & Training (CST) team on small to large-sized studies or programs, interact with other functional groups, vendors, license holders, Key Opinion Leaders (KOLs), and Sponsors. May serve as a Project Lead in CST stand-alone projects and serves as a Functional Lead in full scope or multiple protocol projects.
- Manage CST deliverables pertaining to scoped services vendors (i.e., Rater Training vendors), scale license holders and/or KOLs.
- Manage all aspects of license procurement, scale translation requirements, and paper scale worksheet development.
- Manage creation of all CST service-related documentation and templates. This may include managing development and testing of the CST Study Training and Engagement Portal (STEP) to meet study-specific Rater Training needs.
- Manage all aspects of CST services to ensure quality and timely delivery and implementation.
- Develop and maintain the study-specific CST plan in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Contribute to relevant functional project plans to ensure alignment with the CST plan.
- Provide regular and timely status updates to internal and Sponsor project teams regarding CST scoped services, including risks to delivery such as timeline delays and serve as a central point of contact for CST-related project issues and solicit support from LM or CST SMEs, as required.
- Create and maintain CST metric reports for scoped services, for delivery to client.
- Attend Trusted Process, internal and Sponsor meetings as a lead CST representative to discuss CST strategy, address CST-related agenda topics, and provide status reports.
- Ensure CST project documentation is maintained on an ongoing basis and ensure required documentation is filed completely and accurately in the Trial Master File (TMF).
- Identify risks and develop mitigation plan as required.
- Participate in Sponsor, internal or agency audits and inspections, as required.
- Responsible for management of CST scope, including identification of CST out of scope activities and overburn, including revenue recognition (if delegated this task by study lead or if serving as a Project lead in stand-alone study), invoice management (tracking and confirmation of payment), and/or KOL contract and management, etc. May participate in internal financial review meetings to review CST overburn or financial risk, as needed.
- Plan, manage, and request CST resources (e.g., CST Project Specialist, CST Clinical Scientist, CST Assessment Scientist, etc) and provide CST resource updates for assigned projects.
- Train and mentor internal team members.
Qualifications; - Bachelor's Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred.
- Prior experience in study coordination, contract research organization (CRO), pharmaceutical, biotechnology or rater training vendor company preferred.
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade.
- Good organizational, planning, customer service, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. Ability to manage time and work independently.
- High level of competency in English language.
- Proficiency with MS Office Applications.
- Strong knowledge of Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines and other applicable regulatory requirements.
- Ability to travel as necessary (up to 25%).
Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.
