Associate - Trial Capabilities
2 days ago
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 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 Trial Capabilities Associate provides clinical trial capabilities in support of clinical development. The Associate is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. The Associate is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, records management and site training. The Associate will ensure inspection readiness at all time following GCP and any local/regional requirements.
**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 with sites, Lilly functions, clinical research organization to enable start-up and maintain an active collaboration with sites during maintenance and close-out
- Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
- Coordinate the management and delivery of clinical trial material to ensure support of site initiation
- Implement internal clinical trial systems (e.g. IMPACT, Vault Clinical, TrialForce) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements
- Ensure complete, accurate and readily available Trial Master File
**Minimum Qualification Requirements**
- Bachelor’s degree preferably in a scientific or health related field
- One (1) year 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 management processes and skills
- Appreciation of / experience in compliance-driven environment
- Effective communication, negotiation, and problem-solving skills
- Self-management and organizational 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 Associate
3 days ago
Petaling Jaya, Malaysia Eli Lilly Full timeAt 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 Assistant
4 days ago
Petaling Jaya, Malaysia Eli Lilly Full timeAt 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 days ago
Petaling Jaya, Malaysia ELI LILLY ASIA PACIFIC SSC SDN BHD Full time**Primary Responsibilities**: 1. Clinical Trial Payment Responsibilities - manage the purchase to pay process for clinical trial investigator payments: Vendor creation and management Purchase Order (PO) creation and maintenance Processing study visit payments and invoiceable items, including site close-out payment reconciliation Identify, communicate, and...
-
Trial Capabilities Assistant-10
4 days ago
Petaling Jaya, Malaysia Lilly Full timeAt 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 Trial Associate
3 days ago
Petaling Jaya, Selangor, Malaysia Eli Lilly and Company Full timeAt Eli Lilly and Company, we are a global healthcare leader dedicated to making life better for people around the world.We unite caring with discovery to 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. Our employees work together...
-
Trial Operations Specialist
3 days ago
Petaling Jaya, Selangor, Malaysia Eli Lilly and Company Full timeEli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world.We are committed to improving the understanding and management of disease, and giving back to our communities through philanthropy and volunteerism. Our employees work together to achieve this mission, putting people first and...
-
Clinical Trials Manager
4 days ago
Petaling Jaya, Selangor, Malaysia George Clinical Pty Full timeAbout the RoleThis Senior Clinical Research Associate position requires a strong understanding of clinical research principles and practices. The successful candidate will have experience in creating and implementing research protocols, writing reports, and identifying and mitigating trial risks.Key ResponsibilitiesManage and implement research protocols to...
-
Clinical Trial Operations Coordinator
4 days ago
Petaling Jaya, Selangor, Malaysia Parexel International Full timeJob SummaryWe are seeking a highly motivated Clinical Research Associate I to join our team at Parexel International. As a key member of our clinical operations group, you will be responsible for managing clinical trials from site identification to close out.Key Accountabilities:Start-up Phase:Act as Parexel's direct point of contact with assigned sites...
-
Global Clinical Development Coordinator
3 days ago
Petaling Jaya, Selangor, Malaysia Eli Lilly and Company Full timeWe are seeking a highly skilled and experienced Clinical Trial Associate to join our team at Eli Lilly and Company.The successful candidate will have a strong background in clinical research and experience in managing clinical trials. They will be responsible for providing clinical trial capabilities in support of clinical development, ensuring that...
-
Associate Attorney Advisor
6 days ago
Petaling Jaya, Selangor, Malaysia Malaysianbar Full timeWe are looking for a talented Legal Associate (Litigation) to contribute to the success of our law firm. As a key member of our team, you will be responsible for attending trials, hearings, and case managements, as well as drafting legal documents.The successful candidate will have a strong background in commercial litigation and be able to work effectively...
-
Clinical Research Associate Specialist
4 days ago
Petaling Jaya, Selangor, Malaysia Parexel International Full timeJob DescriptionThe Clinical Research Associate I will be responsible for managing clinical trials from site identification to close out. The role involves acting as Parexel's direct point of contact with assigned sites, ensuring overall integrity of study implementation and adherence to study protocol at clinical sites.Key Responsibilities:Site...
-
Legal Associate
2 days ago
Petaling Jaya, Selangor, Malaysia Malaysianbar Full timeJob Description:The position of Civil Litigation (Legal Associates) is available at Armiy Rais, a reputable law firm in Malaysia. As a junior lawyer, you will be responsible for preparing cause papers and submissions, attending trials and hearings, and assisting lawyers in various tasks.Responsibilities:Prepare all cause papers and submissions.Attend trial,...
-
Law Firm Associate
16 hours ago
Petaling Jaya, Selangor, Malaysia Malaysianbar Full timeAbout the RoleThe Dispute Resolution Team is looking for a talented Law Firm Associate with at least 3 years PQE experience. In this position, you will be responsible for handling various aspects of litigation, including case management, legal research, and client communication.Key ResponsibilitiesManage and oversee cases from inception to completionConduct...
-
Senior Clinical Site Manager
3 days ago
Petaling Jaya, Selangor, Malaysia Eli Lilly and Company Full timeWe are seeking a highly skilled and experienced Trial Operations Specialist to join our team at Eli Lilly and Company.The successful candidate will have a strong background in clinical research and experience in managing clinical trials. They will be responsible for providing clinical trial capabilities in support of clinical development, ensuring that...
-
Site Management Specialist
4 days ago
Petaling Jaya, Selangor, Malaysia Parexel International Full timePosition OverviewParexel International is seeking a Clinical Research Associate I to manage clinical trials from site identification to close out. This is an exciting opportunity for a motivated and experienced professional to join our team and contribute to the success of our clients.Responsibilities:Clinical Trial Operations:Act as Parexel's direct point...
-
Clinical Study Associate
4 days ago
Petaling Jaya, Selangor, Malaysia IQVIA Argentina Full timeWe are seeking a skilled Clinical Study Associate to support our sponsor-dedicated team in a client-facing role. As a vital part of our team, you will perform daily administrative tasks to support clinical projects and update clinical systems and databases.You will also perform general administrative tasks as needed. You will have excellent communication,...
-
Director of Clinical Research
4 days ago
Petaling Jaya, Selangor, Malaysia George Clinical Pty Full timePosition SummaryThis Senior Clinical Research Associate role is a key member of our research team. The successful candidate will be responsible for overseeing the conduct of clinical trials, ensuring compliance with regulatory requirements, and identifying opportunities for process improvements.Essential Skills and QualificationsDegree in life sciences or a...
-
Research Site Liaison Manager
4 days ago
Petaling Jaya, Selangor, Malaysia Parexel International Full timeAbout the RoleParexel International is seeking a Clinical Research Associate I to manage clinical trials from site identification to close out. As a key member of our team, you will act as Parexel's direct point of contact with assigned sites, ensuring overall integrity of study implementation and adherence to study protocol at clinical...
-
Commercial Litigation Expert
6 days ago
Petaling Jaya, Selangor, Malaysia Malaysianbar Full timeWe are looking for a dedicated and hardworking Legal Associate (Litigation) to join our team at Malaysianbar. As a key member of our team, you will be responsible for attending trials, hearings, and case managements, as well as drafting legal documents.The successful candidate will have a strong background in commercial litigation and be able to work...
-
Research Scientist Lead
4 days ago
Petaling Jaya, Selangor, Malaysia George Clinical Pty Full timeJob OverviewThe Senior Clinical Research Associate is responsible for overseeing the conduct of clinical trials at George Clinical Pty. This role involves managing research protocols, ensuring compliance with regulatory and ethical standards, and monitoring the research process.