Associate Director Global Trial Lead - Medical Affairs Operations
Kelly is currently seeking a Global Trial Leader Medical Affairs Operations for one of the largest global pharmaceutical companies in the world. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc..
This role is a full-time, offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise.
The Global Trial Leader Medical Affairs Operations provides global, regional or complex local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end to end project management including start-up, execution, close-out, analysis and reporting. Further, services will ensure the teams operational activities are in line with country specific regulations and trial teams are delivering high 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. Partners with the Clinical Program Leader (CPL), Clinical Operations Head (COH), Global Clinical Trial Assistant (GCTA MAO), and other Global Trial Leaders (GTL) to ensure overall study delivery at the country level.
Services rendered will adhere to applicable to SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
Complies with relevant training requirements.
Prepares high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs. Responsible for 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 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 and works with GCO/CRO staff in the set up and coordination of Investigator meetings, if applicable.
Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study drug supply.
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 creating, reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.
Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
With focus on quality, participates in preparation for, and conduct of, HA inspections and Internal Quality Assurance (QA) audits. Works closely with CPL to ensure CAPA is implemented for audits/inspections or any quality related issues or concerns.
Ensures accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.
Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
May contribute as a mentor, champion, or representative of functional area in process initiatives, as required and if applicable.
If applicable, region specific deliverables will be specified.
Advanced: o Autonomy with execution of Global, Regional and local trial management services. o Depth of knowledge with Global, Regional and local trial management services.
o Process leadership.
Education and Experience Requirements:
Bachelor’s degree or equivalent required, preferably in Life Sciences.
8 years of clinical research experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.
4+ years leading Global Clinical Trials including trial creation, timelines, budgets and so on.
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