Local Trial Manager

Local Trial Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements.

Tasks & Responsibilities:

• Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements.

• Prepares or contributes to high level budget estimate in response to Request for Service's followed by detailed budget proposal. Ensures overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.

• Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.

• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.

• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.

• Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.

Essentials Requirements:

• BA/BS degree.

• Degree in a health or science related field.

• Minimum of 2 years of local trial management experience in the pharmaceutical industry or CRO and previous experience as Clinical Research Associate.

• Specific therapeutic area experience may be required depending on the position.

• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.

• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.

• Excellent decision-making and string financial management skills.

• Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.

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