Country Study Specialist

China, Shanghai, Shanghai

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Main Responsibilities and Accountabilities:

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
  • 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:

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.

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.

Roche is an equal opportunity employer.

Research & Development, Research & Development > Clinical Operations