Main Responsibilities and Accountabilities:

1. Provide essential operational co-ordination and support to Country Study Managers (CSMs) and Local Study Teams (LSTs):

Project Management:

• Identify, develop and maintain operational templates and tools based on the needs of

assigned studies.

• 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.

Compliance:

• 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.

Relationship Management:

• Build and maintain effective working relationships with LST members and study site

staff.

• 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.

2. Develop Operational Elements at a Country Level:

Coordination:

• 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.

Localization:

• Ensure accurate translation of all documents, as applicable.

• Provide required local customs documentation to meet country requirements for importation / exportation, as applicable.

3. 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.

Qualifications:

• 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.

Other:

• Availability to travel domestically and internationally if required.