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Local Trial Manager

3 months ago

Mumbai, India Johnson and Johnson Full time
Position Title: Local Trial Manager

Position Summary:

The Local Trial Manager is responsible for local management of a clinical trial (or Medical Affairs

data generation activity) in a country or countries.The LTM 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 LTM 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 LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants

(CTA), Site Managers (SM) and LTM roles.The LTM may have some site management responsibilities.

The LTM may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single

country as described in GCO procedural documents.

Principal Responsibilities:

1.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.

2.Collaborates with the Global Product Lead (GPL), CTM/GTL, 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

4.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.

5.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

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 may 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.

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

investigator meeting

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).

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 CTM/GTL and FM as needed

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

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.

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

regulatory requirements

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 contributes to process improvement, training and mentoring of CTAs, SM and other LTMs.

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

22.May assumes additional responsibilities or special initiatives such as "Champion" or "Subject Matter

Expert".

23.May represents functional area in process initiatives as required

Principal Relationships:

Primary Reporting Structure: Reports to a Functional Manager

Primary interfaces: Functional Manager/CRM, CTAs, SMs, CTM/GTLs, Study Responsible Physicians (SRP),

Quality & Compliance Managers/Specialists, Local Safety Officer

Other Internal Interfaces: R&D Country Head, Regional Therapeutic Area Experts (RTAEs), Contracts &

Grants, CTM/GTL, R&D study team (e.g., SRP), data management and Medical Affairs (when applicable)

External Interfaces:

Trial Site Personnel, external vendor representatives, Ethics Committee and others as requiredEducation and Experience Requirements:

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

is required.

Minimum 6 to 10 years of 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.