If you want an exciting project where you can use your previous clinical research expertise and develop and grow your career in the Clinical Trials field, then this is the opportunity for you!
Major Accountabilities:
1. Agree with colleague/customer team and Line Functions on realistic project and study timelines. Escalate to a higher level in the organization if no agreement can be achieved or support the Sr. CPM.
2. Lead and manage a multidisciplinary cross-functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety, etc.) or support the Sr. CPM in the effective planning, regular re-evaluation, and implementation of assigned clinical studies.
3. Responsible for investigators meeting organization and all internal meetings related to the clinical study execution and operational excellence.
4. As applicable, directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and conduct, reviewing site performance, protocol deviations, ongoing risk assessment, and timely issue resolution in alignment with local regulation requirements.
5. As applicable, responsible for the review of all site visit related reports and quality control of monitoring activities in a timely manner.
6. In partnership with Clinical Operations Specialists (COS) (where applicable), responsible for the set up and maintenance of the Trial Master File (TMF), Clinical Trial Management System (CTMS), and other required systems as appropriate.
7. Responsible for accuracy of study information in all study databases and tracking systems. Responsible for (or support the Sr. CPM where applicable) the preparation and presentation of the study budget to colleague/customer representatives.
8. Execute clinical services and meet planned deliverables, in line with defined roles and responsibilities agreed with customers.
9. Lead innovation by identifying areas for process or technology improvements and participate in continuous improvement initiatives. Act as a mentor, including supporting the training and onboarding of new associates.
Requirements:
1. Relevant educational background in life sciences/Healthcare (Ideally a Bachelor's Degree or above in life sciences) or equivalent combination of education, training, and experience.
2. Approximately 5 years of Clinical Operations experience with managerial experience in designing, planning, executing, reporting, and publishing clinical studies (interventional and non-interventional clinical studies, early to late phase) in a pharmaceutical company or contract research organization.
3. Proven ability to work independently in a complex matrix environment (including remote), including leading cross-functional teams.
4. Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development processes.
5. Demonstrated presentation and diplomacy skills. Negotiation and conflict resolution skills.
6. Strong customer-oriented mindset.
7. Ability to resolve issues with minimal supervision and understand when to escalate.
8. Fluent in English (oral and written).
#J-18808-Ljbffr