Trial Capabilities Manager

2 weeks 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 through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Clinical Trial (Trial Capabilities) Manager leads the clinical trial capabilities in support of clinical development. The manager provides leadership, direction and technical support to the Trial Capabilities Associates/Specialists (TCAs/TCSs) in support of clinical development, focusing on results and driving efficiency to achieve goals and objectives. The manager will ensure inspection readiness at all times through a complete, accurate and readily available Trial Master File (TMF) as per defined TMF document ownership.

**Clinical Trial Capabilities Responsibilities**
- Accountable for meeting and exceeding goals for clinical trial initiation for development programs
- Accountable for ensuring site activation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards.
- Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable during site initiation, maintenance, and close out representing progress to business partners.
- Accountable for prioritization of work to meet portfolio needs.
- Ensure flexibility of resources across trial capabilities teams, and geographies (as applicable).
- Ensure inspection readiness through a complete, accurate and readily available Trial Master File.
- Strategic prioritization and use of internal clinical trial systems (e.g. Vault Clinical) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.
- Accountable to audit and inspection responses and corrective action plans that under affiliate Trial Capabilities’s responsibilities
- Understand, comply, and reinforce local regulations and guidance, Lilly Medical policies and procedures, and good clinical practices (GCP)

**Organizational Leadership**
- Identify and ensure shared learning across the Trial Capabilities organization.
- Build capabilities in the function through the development and improvement of processes, tools and training and partnering with clinical system functions to leverage technology to increase efficiency of clinical trial capabilities and resources.
- Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning.
- Manage staff compliance to local regulations and guidance, Lilly Medical policies and procedures, and good clinical practices (GCP).

**People Management and Development**- Recruit, develop, and retain an operationally capable workforce skilled and knowledgeable in clinical development.- Effectively manage an agile organization that continuously meets the needs of a changing portfolio.
- Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment-based decision making in clinical delivery.

**Minimum Qualification Requirements**
- Bachelor’s degree preferably in a scientific or health related field.
- Five (5) years clinical research experience or relevant experience preferred.
- Understanding of the overall clinical development paradigm and the importance of efficient site initiation.
- Previous supervisory experience.
- Strong leadership skills and ability to influence others and lead across the business.
- Project management processes and skills.
- Appreciation of/experience in compliance-driven environment.
- Effective communication, negotiation, and problem-solving skills.
- Self-management and organizational skills.
- Excellent computer skills.
- Language capabilities - English (read, write, conversation)

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

WeAreLilly

  • Trial Capabilities Manager

    2 weeks ago

    Subang Jaya, Selangor, 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...

  • Specialist - Trial Capabilities

    2 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

    3 weeks 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...

  • Trial Capabilities Associate

    2 weeks 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 Assistant-10

    2 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...

  • Specialist - Trial Capabilities

    2 weeks ago

    Subang Jaya, Selangor, 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 Assistant-10

    2 weeks ago

    Subang Jaya, Selangor, 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...

  • Local Trial Manager

    3 weeks 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...

  • Clinical Trial Associate

    2 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...

  • Local Trial Manager, Global Clinical Operations

    2 weeks 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...

  • Local Trial Manager, Global Clinical Operations

    3 weeks 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...

  • Clinical Trial Associate

    2 weeks ago

    Subang Jaya, Selangor, 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 into...

  • Trial Capabilities Associate

    2 weeks ago

    Subang Jaya, Selangor, Malaysia Manpower Group Malaysia Full time

    Minimum Qualification Requirements At least Bachelor's degree preferably in a scientific or health related field, postgraduate degree is also welcomed 14 years clinical research experience or relevant experience preferred Understanding of the overall clinical development paradigm and the importance of efficient site activation Applied knowledge of project...

  • Trial Capabilities Associate

    2 weeks ago

    Petaling Jaya, Malaysia Manpower Group Malaysia Full time

    Minimum Qualification Requirements - At least Bachelor’s degree preferably in a scientific or health related field, postgraduate degree is also welcomed - 1-4 years clinical research experience or relevant experience preferred Understanding of the overall clinical development paradigm and the importance of efficient site activation - Applied knowledge of...

  • Clinical Trials Assistant

    4 weeks 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

    2 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,...

  • Local Trial Manager, Global Clinical Operations

    2 weeks ago

    Subang Jaya, Selangor, 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 contact...

  • Local Trial Manager, Global Clinical Operations

    4 weeks ago

    Subang Jaya, Selangor, 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. 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...

  • Local Trial Manager, Global Clinical Operations

    1 month ago

    Subang Jaya, Selangor, 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. 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...

  • Trial Capabilities Associate

    2 weeks ago

    Subang Jaya, Selangor, Malaysia AGENSI PEKERJAAN ICONIC MALAYSIA GW SDN. Full time

    Manage investigator payments and any other financial transactions Escalate issues to aligned management Understand, comply, and reinforce local regulations and guidance, Lilly Medical policies and procedures, and good clinical practices (GCP)- Required Skills:_ Language: English and Korea well (read, write, conversation) Understanding of the overall clinical...