Lead Local Trial Manager

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Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Hyderabad, Andhra Pradesh, India, Mumbai, India

Job Description:

Experience required:

Independent project management in E2E clinical operations in phase II - Phase IV clinical trials. atleast 4+ years of independent project management and total clinical research experience of 12+ years including on-site monitoring.

Position Summary:

A Lead, Local Trial Manager is considered as a senior trial management role with at least 4 years of clinical trial management experience or more than 6 years of clinical monitoring experience.

This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.

The Lead, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.

The Lead, Local Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Lead, Local Trial Manager actively leads or contributes to process improvement; training and mentoring of other LTMs and Site Managers (SM).

Compared to Associate, Local Trial Manager and Senior, Local Trial Manager roles, a Lead, Local Trial Manager is often assigned to more complex protocols and can work across Phase 1 – 3 studies in multiple therapeutic areas as needed to drive business needs.

The Lead, Local Trial Manager may also perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country as described in GCO procedural documents.

Principal Responsibilities:

1. May be delegated by Functional Manager (FM)/Clinical Research Manager (CRM) to lead country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and TDM/TDL. Implements any local criteria for site selection. Ensure consistent conduct of Site Qualification Visits and instruct teams on appropriate follow-up of Site Qualification Visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.

2. Collaborates with the Program Delivery Leader (PDL), TDM/TDL, local management/Country Head and other study team member to select final site list.

3. Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs. May be delegated by study team to initiate document development for global/regional studies.

4. Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents, and applicable regulations.

5.Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment

planning, contingency and risk management, and budget forecasting. Expected to guide Associate LTMs.Ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.

6. Maintains and updates trial management systems. Uses study tools and management reports available to analyse trial progress. May be required to support Country Heads in generating country performance reports.

7. Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.

8. May submit requests for vendor services and required to support vendor selection.

9. In certain situations, may assist in negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines. Expected to guide Associate LTMs.

10. Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting. Will be expected to present and lead specific sessions and to facilitate discussion groups. May be required to be the organizer for Investigator Meetings.

11.Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes). May be required to provide guidance to Associate LTMs.

12.Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the TDM/TDL and FM/CRM as needed. Expected to mentor and guide Associate LTMs.

13.Reviews and approves site and local vendor invoices as required. Manages local study supply, as required. Expected to guide Associate LTMs.

14.Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents, and applicable regulations. Expected to guide Associate LTMs.

15.Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements. Expected to guide Associate LTMs.

16.Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits.

17.Complies with relevant training requirements.

18.Acts as subject matter expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent GCO on cross functional teams.

19.Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.

20.Actively leads or contributes to process improvement, training and mentoring of CTAs, SMs and other LTMs.21

May be asked to conducts accompanied site visits with SM as delegated by FM/CRM. May be required to provide guidance to Associate LTMs.

22.Expected to assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.

23.Expected to represent functional area or lead country, regional, and global process initiatives as required.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Required Skills:

Preferred Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)