Local Trial Manager

2 weeks ago

Mumbai, Maharashtra, India Johnson & Johnson Full time

Position Title Local Trial ManagerPosition 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 requiredPrincipal 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 requiredQualificationsEducation 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 candidates 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 Johnson Johnson

  • Clinical Trial Manager

    3 weeks ago

    Mumbai, Maharashtra, India Lifelancer Full time

    Job Title: Clinical Trial Manager ((Cardiovascular, Renal & Metabolic Disease (CVRM)) Job Location: Navi Mumbai, Maharashtra, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Medpace is currently looking for Clinical Trial Manager (CTM) to lead global clinical research studies. This position is fully office-based in our...

  • Global Clinical Trials Project Lead

    7 days ago

    Mumbai, Maharashtra, India Novo Nordisk Full time

    Key ResponsibilitiesCoordinate clinical trial set-up in partnership with the COM and CDC-TM, ensuring appropriate site and resources allocation.Manage local clinical projects, ensuring they are executed in a timely and effective manner within budget and complying with regulatory requirements.Provide clinical trial related communication and insight to...

  • Global Clinical Trials Coordinator

    5 days ago

    Mumbai, Maharashtra, India Novo Nordisk Full time

    The Clinical Research department at Novo Nordisk India is based in Mumbai and has a team of dedicated professionals working on cutting-edge clinical trials in the field of diabetes and other serious chronic diseases. As a Regulatory Affairs Specialist, you will have the opportunity to work with a fast-paced and dynamic team focused on delivering high-quality...

  • Clinical Trial Associate

    2 weeks ago

    Mumbai, Maharashtra, India Bristol Myers Squibb Full time

    **Working with Us**Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Clinical Trial Manager )

    3 weeks ago

    Mumbai, Maharashtra, India Lifelancer Full time

    Job Title: Clinical Trial Manager ((Cardiovascular, Renal & Metabolic Disease (CVRM)) Job Location: Navi Mumbai, Maharashtra, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities...

  • Clinical Trial Project Manager

    9 hours ago

    Mumbai, Maharashtra, India IQVIA Full time

    Job OverviewThe Clinical Trial Project Manager will be responsible for managing all laboratory aspects of assigned clinical trial projects for a customer or a specific program. This includes acting as the main point of contact for the customer after study award and throughout the entire study lifecycle.Essential Functions:Study Setup and Planning: Facilitate...

  • Clinical Project Manager

    5 days ago

    Mumbai, Maharashtra, India Novo Nordisk Full time

    At Novo Nordisk, we are committed to creating innovative solutions for people with serious chronic diseases. As a Clinical Project Manager, you will play a critical role in driving the success of our business by coordinating clinical trial set-ups at a local level and ensuring appropriate site and resource allocation.Key Responsibilities:Coordinate clinical...

  • Clinical Trials Analysis Manager

    7 days ago

    Mumbai, Maharashtra, India Johnson & Johnson Full time

    About the PositionWe are seeking an experienced Statistical Programmer to lead our clinical trials analysis efforts. The successful candidate will have advanced knowledge of statistical programming methods and languages.Key ResponsibilitiesDesigning and developing programs in support of complex clinical data analysis and reporting.Applying technical and...

  • Clinical Trials Reviewer

    2 days ago

    Mumbai, Maharashtra, India Tata Consultancy Services Limited Full time

    Job OverviewTata Consultancy Services Limited is hiring a Clinical Trials Reviewer to oversee the quality of patient data.Key Responsibilities:Ensure data accuracy by reviewing subject-level data for inconsistencies.Work closely with the design team to develop effective eCRFs.Assess investigation product dosing strategies.Investigate and document all adverse...

  • Clinical Research Associate Manager

    7 days ago

    Mumbai, Maharashtra, India Novo Nordisk Full time

    About the RoleWe are seeking an experienced Clinical Research Associate Manager to join our dynamic team in Mumbai. As a key member of our Clinical Medical Regulatory department, you will be responsible for coordinating clinical trial set-up at a local level, managing local clinical projects, and providing clinical trial related communication and insight to...

  • Cra Manager

    7 days ago

    Mumbai, Maharashtra, India Novo Nordisk Full time

    By continuing to use and navigate this website you are agreeing to the use of cookies Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading Category xc3 x97Select how often in days to receive an alert xc3 x97Select how often in days to receive an alert CRA ManagerCategory Clinical DevelopmentLocation Mumbai...

  • Local Patients Safety Lead

    3 weeks ago

    Mumbai, Maharashtra, India Lifelancer Full time

    Job Title: Local Patients Safety Lead - Mumbai Job Location: Maharashtra Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Mid-Senior level The PositionLead and develop the India Patient Safety & Pharmacovigilance (LPV) Team and define the Local PSPV strategy based on the framework provided by global PSPV.Ensures the...

  • Localization Engineer

    3 weeks ago

    Mumbai, Maharashtra, India myGwork Full time

    This job is with RWS, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Localization Engineer Job LocationsIN-MumbaiPosted Date2 days ago(04/03/2025 03:39)Job ID2025-4617# of Openings1Banding4 Job Purpose You will be an active member of the...

  • Localization Engineer

    2 weeks ago

    Mumbai, Maharashtra, India myGwork Full time

    This job is with RWS, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Localization Engineer Job LocationsIN-MumbaiPosted Date2 weeks ago(04/03/2025 03:39)Job ID2025-4617# of Openings1Banding4 Job Purpose You will be an active member of the...

  • Localization Engineer

    2 weeks ago

    Mumbai, Maharashtra, India myGwork Full time

    This job is with RWS, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Localization EngineerJob LocationsIN-MumbaiPosted Date1 week ago(04/03/2025 03:39)Job ID2025-4617# of Openings1Banding4Job...

  • Sales Lead

    2 weeks ago

    Mumbai, Maharashtra, India AdMax Local Full time

    Position: Sales Lead Location: Remote (India) Shift Timings: US Hours (PST) About Us: AdMax Local is a dynamic SaaS company revolutionizing marketing strategies for small and medium-sized businesses (SMBs) across the United States. Our platform, Amp'd Local, delivers personalized, data-driven recommendations, enabling businesses to optimize their marketing...

  • Customer Experience Manager

    23 hours ago

    Mumbai, Maharashtra, India Stay Local INC Full time

    Role OverviewWe are seeking a skilled Guest Services Associate to join our team at Stay Local INC.Key ResponsibilitiesHandle guest inquiries and resolve any issues promptly and professionallyMaintain accurate records of guest interactions and feedbackCollaborate with internal teams to ensure timely resolutions to guest concernsDevelop and implement...

  • Financial Manager for Local Productions

    4 days ago

    Mumbai, Maharashtra, India Amazon Full time

    Company OverviewAmazon Prime Video is a leading streaming service in India, shaping the future of digital video entertainment. We are seeking a Production Finance Manager to oversee the financials of Local Original productions in India.This is an exciting opportunity to join one of the most innovative businesses at Amazon, directly supporting a...

  • Associate Localization Engineer

    3 weeks ago

    Mumbai, Maharashtra, India myGwork Full time

    This job is with RWS, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Associate Localization Engineer Job LocationsIN-MumbaiPosted Date2 weeks ago(18/02/2025 06:11)Job ID2025-4605# of Openings1Banding2 Job Purpose You will be an active member of the...

  • Local Head Proposals

    3 weeks ago

    Mumbai, Maharashtra, India John Cockerill Full time

    Location - Mumbai, India Nature and scope of the mission The local head of proposals is responsible of a technical team (+/- 10 to 15 people) for all technical and estimating aspects of a project proposal from initial request stage to firm binding commitment with our client. He collaborates in tandem with the local head of sales who oversees commercial,...