Lead Local Trial Manager - Mumbai/Hyderabad/Bangalore

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
IN004 Bangalore, IN022 Hyderabad, Mumbai, India

Job Description:

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.Helps establish standard operating procedures for clinical trial project management, and constructs templates for use during clinical trials.
Constructs systems to facilitate the process of clinical trial phases to ensure staff are able to complete testing and analysis in a timely and effective manner.
Directs individuals during regulatory inspections to ensure staff is aware of standard procedures and expectations.
Assesses and maintains in-depth knowledge of the department's study protocol and related procedures to stay up-to-date on the company's operations and have the ability to compare to industry standards and trends.
Implements operational compliance with relevant regulatory and quality standards in accordance with federal and international requirements.
Conducts on-site visits with clients, stakeholders, and other entities and records contact reports to inform others of the clinical trial project team's operations an...