Description

l Senior Local Trial Manager is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. 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. is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that arecompliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.

l Actively leads or contributes to process improvement; training and mentoring of other LTM s and Site Managers (SM).

l Compared to LTM roles, an Senior LTM is often assigned to more complex protocols and can workacross Phase 1 – 3 studies in multiple therapeutic areas as needed to drive business needs.

l May also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for singlecountry as described in GCO procedural documents.

l Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and CTM/GTL. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.

l Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and otherstudy team member to select final site list.

l 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

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

l 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.

l Maintains and updates trial management systems. Uses study tools and management reports available to analyse trial progress

l 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.

l May submit requests for vendor services and may support vendor selection.

l 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.

l Adheres to finance reporting deliverables and timelines.

l Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting

l 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).

l Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed

l Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.

l Prepares country specific informed consent in accordance with procedural document/templates.

l Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.

l Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements.

l Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits Complies with relevant training requirements.

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

l 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.

l Actively leads or contributes to process improvement, training and mentoring of CTAs, SM and other LTMs.

l Conducts accompanied site visits with SM as delegated by FM.

l Assumes additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.

l Represents functional area in process initiatives as required

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

l Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including GCP and local regulatory requirements.

l Willingness to travel with occasional overnight stay away from home.

l Strong leadership skills. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills

l Strong experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs.

l Demonstrated ability to lead initiative/small teams.

l Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel in different disease areas, if required.

Qualifications

A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)

is required.

Solid pharmaceutical and/or clinical trial experience is preferred (including site

monitoring experience), however other relevant experiences and skills may be considered by the hiring

manager when considering the candidate’s eligibility.

Specific therapeutic area experience may be required depending on the position. Should have solid

understanding of the drug development process including GCP and local regulatory requirements.

Willingness to travel with occasional overnight stay away from home.

Solid leadership skills. Solid communication and computer skills required. Proficient in speaking and writing

the country language and English language. Excellent written and oral communication skills

Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred. The

ability to lead initiative/small teams.

Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in

parallel.