Local Trial Manager, Global Clinical Operations

6 months ago

Petaling Jaya, Malaysia Johnson & Johnson Full time

**Position Summary**:

- The Local Trial Manager III (LTM III) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM III 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 III 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 III role actively leads or contributes to process improvement; training and mentoring of other LTM s and Site Managers (SM).
- Compared to LTM I and LTM II roles, an LTM III 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 LTM III 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**:

- 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.
- Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list.
- 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
- 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.
- 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.
- Maintains and updates trial management systems. Uses study tools and management reports available to analyse trial progress
- 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.
- May submit requests for vendor services and may support vendor selection.
- 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.
- Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting
- 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).
- 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
- Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.
- 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.
- Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements.
- Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits
- Complies with relevant training requirements.
- 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.
- Actively leads or contributes to process improvement, training and mentoring of CTAs, SM and other LTMs.
- Conducts accompanied site visits with SM as delegated by FM.
- Assumes additional responsibilities or special initiatives such as “Champion” or “Subject

  • Local Trial Manager, Global Clinical Operations

    7 months ago

    Petaling Jaya, Malaysia Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Local Trials Manager to join our Global Clinical Operations team located in Bandar Sunway. **Position Summary**: - The Local Trial Manager III (LTM III) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM III is the primary point of...

  • Local Trial Manager

    6 months ago

    Petaling Jaya, Malaysia IQVIA Full time

    As Local Trial Manager you will be responsible for local management of a clinical trial in a country or countries, managing the operational aspects of projects to meet contractual requirements. You will act as primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in...

  • Trial Capabilities Associate

    6 months ago

    Petaling Jaya, Malaysia Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Trial Capabilities Manager

    6 months ago

    Petaling Jaya, Malaysia Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Clinical Trials Assistant

    6 months ago

    Petaling Jaya, Malaysia IQVIA Full time

    **Responsibilities**: - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. - Assist the clinical team with the preparation, handling, distribution, filing,...

  • Clinical Trials Assistant

    7 months ago

    Petaling Jaya, Malaysia IQVIA Full time

    **Responsibilities**: - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. - Assist the clinical team with the preparation, handling, distribution, filing,...

  • Specialist - Trial Capabilities

    8 months ago

    Petaling Jaya, Malaysia Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate - Trial Capabilities

    7 months ago

    Petaling Jaya, Malaysia Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...

  • Clinical Trial Associate

    6 months ago

    Petaling Jaya, Malaysia Agensi Pekerjaan & Perundingcara Bright Prospect Sdn Bhd Full time

    To collect and submit regulatory documents to the Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site. - Track and ensure site compliance to required training and effectively drive timelines aligned with a company priority. - To ensure the investigator sites meet requirements to enroll study participants...

  • Trial Capabilities Assistant-10

    8 months ago

    Petaling Jaya, Malaysia Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Clinical Quality Associate Director

    8 months ago

    Petaling Jaya, Malaysia AstraZeneca Full time

    The Clinical Quality Associate Director (CQAD) in general, is responsible for the maintenance and further development, and the communication of high-quality standards in the delivery of clinical studies. This includes a key role in ensuring that the training needs in the local SMM (Site Management & Monitoring) team are fulfilled in cooperation with the...

  • Local Study Associate Director

    8 months ago

    Petaling Jaya, Malaysia AstraZeneca Full time

    To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform...

  • Clinical Operations Manager

    8 months ago

    Petaling Jaya, Malaysia IQVIA Full time

    **Job Overview** Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives. **Essential Functions** - Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and...

  • Clinical Trial Educator

    7 months ago

    Petaling Jaya, Malaysia IQVIA Full time

    **Job Overview** CTEs collaborate with research staff and other stakeholders to drive trial recruitment and to support study specific training needs. The CTE acts as a strategic partner to both external and internal stakeholders to optimise the site experience and performance. Leads the relationship management and communication of medical and scientific...

  • Clinical Assistant

    7 months ago

    Petaling Jaya, Malaysia Parexel Full time

    Petaling Jaya, Selangor, Malaysia **Job ID** R0000023665 **Category** Clinical Trials **ABOUT THIS ROLE**: **Project Trails Master File** - Filling and Archiving paper wet-ink documents in the Central Files office location as per the Trial Master File plan - Photocopy, print, distribute and retrieval of documents, as needed - Support on creating and...

  • Associate Director, Clinical Operations

    6 months ago

    Petaling Jaya, Malaysia IQVIA Full time

    Direct a team of clinical professionals to support and deliver clinical research projects in Singapore and Malaysia, ensuring that projects are effectively resourced and that teams are effectively trained and managed to deliver successful outcomes to customers. Work with senior leadership in formulating and executing effective strategic goals and objectives...

  • Clinical Researh Coordinator

    7 months ago

    Petaling Jaya, Malaysia RF Staffing and Outsourcing Solutions Sdn. Bhd. Full time

    **Responsibilities**: - Initiate investigator site activities, including collection and submission of regulatory documents to Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site, track and ensure site compliance to required training and effectively drive timelines aligned with company priority - Communicate...

  • Clinical Research Associate 2

    4 months ago

    Petaling Jaya, Malaysia IQVIA Full time

    **Essential Functions** - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines - Administer protocol and related study training to assigned sites and...

  • Clinical Specialist

    7 months ago

    Petaling Jaya, Malaysia Solventum Full time

    **Job Description**: The incumbent will contribute to, and support the business unit to achieve sales targets, goals and objectives of the Solventum Dental Division (DSD) business plan, via successful execution of the Marketing and Scientific Affairs & Education (SA&E) plans. Provide specialised clinical support and education to business teams and oral...

  • Medical Lead

    6 months ago

    Petaling Jaya, Malaysia Novartis Full time

    394602BR **Medical Lead - CRM**: Malaysia **About the role** 4! The 4 essential elements that shape our culture: Inspired. Curious. Unbossed. Integrity. Our mission is to discover new ways to improve and extend peoples’ lives. Your passion to build, execute business plans to meet the sales goals, develop effective professional business relationships...