Main Responsibilities and Accountabilities:
Provide essential operational co-ordination and support to Country Study Managers (CSMs) and Local Study Teams (LSTs):
- Identify, develop and maintain operational templates and tools based on the needs of
- Proactive contribution to study start-up and patient recruitment strategies and activities to support efficient trial management.
- Proactive study communication via development and distribution of affiliate newsletters for investigators and LSTs, as required.
- Manage shared study area/s according to Roche standards.
- Responsible for oversight of study-related supplies.
- Support CSM(s) by ensuring that Monitors have site recruitment plans, that site activations occur according to planned timelines and there is timely closure of non-productive sites.
- Ensure appropriate tracking systems and tools are in place to ensure compliance to
regulations, internal policies, ICH-GCP and GPP (when applicable).
- Responsible for the co-ordination and oversight of local affiliate study level audit /
inspection audit action plan activities.
- Responsible for clinical trial data disclosure completion per local regulatory requirements.
- Build and maintain effective working relationships with LST members and study site
- Perform/coordinate protocol and site level feasibility activities including evaluation of patient population and final site selection.
- Support CSM and SSU related activities as required.
- Coordinate/execute local investigator and LST meetings where required.
- Liaise with Roche science/medical teams (either local or global, as required) for timely resolution of questions.
- Acts as a single point of contact for study CRO monitors for monitoring related activities.
- Provide feedback to local vendor management on performance of CTM CRO staff as required.
Develop Operational Elements at a Country Level:
- Provide input into project management and monitoring plans.
- Coordinate study or country communication plan, budget and payment plan based on country financial plan.
- In collaboration with CSM, maintain track and update country level resource plans.
- Create and/or maintain study or country recruitment plan for assigned studies.
- Ensure collection of site level documents to support country ethics approval and health authority processes.
- Ensure all country ethics / HA approvals are in place for assigned studies.
- Ensure accurate translation of all documents, as applicable.
- Provide required local customs documentation to meet country requirements for importation / exportation, as applicable.
Provide proactive project co-ordination and study oversight actively involving respective internal and external LST members:
- Ensure trial management tracking tools are updated in a timely manner to ensure systems are accurate.
- Provide regular status and activity reports to CSMs and relevant LST members.
- Ensure that monitoring reports are being submitted by Clinical Research Organization (CRO) and escalate to CSM as needed; Review monitoring reports in conjunction with CSM as required.
- Manage country-level Trial Master File (TMF) and review for quality.
- Manage the secure document exchange and SUSAR reporting process during the conduct of the study.
- Assist with the review and tracking of safety procedures to ensure they are being followed, escalated and resolved as necessary.
- Ensure database lock activities are within timelines in collaboration with CSM.
- Provide feedback of local suppliers/vendors to vendor manager.
- Ensure local drug label review and approval is conducted to country requirements.
- Identify opportunities for efficiencies and share best practices with other LSTs.
- University Degree or Equivalent preferably in a medical/science-related field.
- Prior work experience demonstrating knowledge and understanding of clinical trials.
- Previous experience managing projects is desirable.
Skills, Experience and Competencies:
- Experience working as part of a team with a proven ability to make an active contribution to the team’s performance and teamwork.
- Able to prioritize and manage multiple tasks with high flexibility.
- Proven project management skills to work with a variety of different systems and
stakeholders and deliver commitments on time and with quality.
- Self-motivated and displays initiative/resourcefulness.
- Ability to work independently with limited supervision.
- Strong attention to detail.
- Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.
- Ability to communicate clearly and accurately in both written and spoken English.
- Availability to travel domestically and internationally if required.