Clinical Operation VP

  • Full Time
  • US

Website AnHeart Therapeutics

Department: Clinical Operation
Report to: CMO (US)

 

MAIN RESPONSIBILITIES:
Perform overall management for assigned projects to ensure timely delivery, data quality, and budget within control.
Act as a study team leader to set up team goals and lead cross-function communication to get there, including but not limited to medical, regulatory, CMC, HR, and finance.
Implement and drive resource strategy for Clinical Operations to meet project deliverables and timelines and changing workloads.
Be accountable in the country for strategy related to Clinical Operations activities including but not limited to, feasibility, allocations, recruitment enablers, trial execution, and local customer relationships related to Clinical Operations (Performs management to but not limited to clinical study start-up from any stages, budget control, initiation, patient enrollment, protocol adherence, CRF compliance, data quality to meet specified ethical, scientific, regulatory needs. Develop and maintain KOL relationships).
Maintain good communications and relationships with 3rd party vendors, including but not limited to CRC, CRA, PM, or DM/Stats if applicable.
Ensure the conduction of the clinical trial in compliance with ICH – GCP guidelines, local regulatory requirements, SOPs, and protocols.
Be accountable for department SOP development as well as renewal.
Support the organization of appropriate training programs. Provide management coaching to the staff.

QUALIFICATIONS:
Minimum of 15 years experience in clinical research and 5-7 years management experience in related fields such as clinical operations (Minimum 5 years of monitoring experience in clinical research).
Master’s degree or above in biological science, pharmacy, or other health-related disciplines.
Good knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Clear and compelling communication.
Strong leadership and influencing skills across geographies and cultural differences.
Advanced ability to problem-solve and conflict resolution.
Operational expertise in risk management and contingency planning.
Proven ability to manage budgets and resources.
Experience in international CROs preferred.
Competent in written and oral English is a must.

 

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