The Senior Clinical Project Manager role is key to the successful set up, conduct and management of clinical operations activities within the company. He/she is responsible for ensuring our customer’s clinical trials are conducted according to internationally recognized ethical principles, ICH-GCP for Drug studies and ISO regulations for studies using Medical Devices as well as their Quality system and SOPs, and in accordance with present budgets. The Clinical Project Manager may also support the Clinical Study Director for specific projects.
Job Specific Duties – Technical:
• Responsible for a successful trial conduct in compliance with study protocol/procedures,
ICH GCP, our customer’s Quality System and other relevant guidelines, within agreed timelines and
budget achieved through leading and coordination of the study and study team/s at all
levels.
• Set up and maintenance of the collaboration with the selected CRO/s, and training of the
internal and external study teams.
• Responsible for contributing to clinical protocols and related documents (e.g. Subject
information Sheet and informed consent) in collaboration with the Clinical Trial Team
(CTT).
• Supporting the clinical trial protocol development process; contribute to the operational and
scientific input given for the development of trial-related documents and processes that
reside in other line functions.
• Assist the clinical management in the set-up of the service agreement with the Clinical
Service Providers (CSP) / Contract Research Organizations (CRO).
• Assist the CROs / CRAs, in identifying appropriate trial sites and manage study set-up,
including responsibility for organizing the SIV meeting when/where required.
• Prepare specific data package for ethics committee submission and review and approve
the country/site specific packages before the submission.
• Assist the CROs/CRAs in the set-up of the trial agreement with the investigational sites
• Develop the trial specific documents and forms, such as Monitoring Plan, Communication
Plan.
• Coordinate the investigator meeting organization and conduct.
• Support the CRAs on study related questions and serve as point of contact for
managing/answering questions relating to trial procedures and subjects eligibility.
• Timely review and approval of the reports for pre-study, initiation, monitoring and close-out
visits.
• Perform site qualification, initiation, interim and study close-out visits when needed
• Regularly update all trial information in the relevant trackers in order to manage accuracy
of information.
• Review and approve all CSP/CRO and study site payments as per financial agreements.
Assist in the ongoing review of the clinical trial medical/scientific data (as needed),
analysis and interpretation including the development of first interpretable results, clinical
trial reports, publications and internal/external presentations.
• Assist the Clinical Director and Drug Safety Coordinator in SAE reporting processes.
• Coordinate pre-audit activities for the nominated trial ensuring a satisfactory outcome is
achieved.
• Contribute to on-boarding, training and mentoring of new clinical associates.
• Ensure our customer is perceived as a reliable business partner.
• Ensure clinical operations are conducted in accordance with ICH-GCP, ISO standards, Medical Device Directive etc. (also US).
• Know, understand and adhere to all safety standards.
Minimum Education and/or Experience Required:
– Master degree in Life Sciences or nursing, with at least 5 years clinical experience.
– PhD, MRPharmS, MB BS, MB ChB (desirable).
– ACRP Certified Clinical Research Coordinator.
– At least 5 years’ experience in the pharmaceutical/medtech industry, implementing the
conduct of studies in accordance with regulations and standards related to Medical Devices
and Pharmaceutical Products.
Additional Experience and/or Qualifications:
– Experience in co-ordination of multicenter national/international studies.
– Thorough knowledge of ICH-GCP, ISO standards (e.g. 13485, 14155), Annex X-Annex II
Medical Device Directive and regular updates of training in the area.
– Must be able to work well independently, as well as being able to work cooperatively in a
team of professionals.
– Candidate should have strong presentation/interaction and time management skills and
experience in providing evidence based scientific and clinical information to the
medical/surgical community.
– Proven ability to establish strong scientific partnerships with key internal and external
stakeholders.
– Good organizational and interpersonal skills.
– 10 – 20% travel required, mostly regional with potential international as necessary.
