Trial Capabilities Associate
3 weeks ago
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, and activities related to clinical finance, record management and site training. The country-based Associate will provide local support to complement the centralized activities performed by Asia Pacific Trial Capabilities Centre to ensure compliance with local requirements/needs.
The Associate will ensure inspection readiness at all times following GCP; any local/regional requirements and Lilly operating procedures and through a complete, accurate and readily available Trial Master File (TMF) as per defined TMF document ownership. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.
Primary responsibilities:
Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ethics review board (ERB) and competent authority (CA) (where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities.
Communicate with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out.
Communicate with Clinical Design, Delivery and Analytics (CDDA) functions and external party / clinical research organization to enable active collaboration during site activation, maintenance, and close-out.
Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
Identify, communicate, and resolve issues. Escalate issues to aligned management and quality as appropriate.
Coordinate the management and delivery of clinical trial material to ensure support of site initiation.
Coordinate translation process for clinical trial documents and oversight of translation quality.
Populate internal systems to ensure accuracy of trial / site performance.
Populate Trial Master Files and libraries for future reference.
Provide feedback and shared learning for continuous improvement.
Anticipate and monitor dynamically changing priorities.
Understand and comply with procurements, legal and financial requirements, and procedures.
Understand, comply, and reinforce local regulations and guidance, Lilly Medical policies and procedures, and Good Clinical Practice (GCP).
Minimum Qualification Requirements
Bachelor’s degree preferably in a scientific or health related field.
At least one 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 fast moving and compliance-driven environment.
Ability to learn and comply with financial and legal guidelines and policies (e.g. budget and contract).
Effective communication, negotiation, and problem-solving skills.
Self-management and good organizational skills. Able to multitask.
Agile and adaptable fast to changes with positive mindset.
Language Capabilities – English (read, write, conversation) and local language, as applicable.
Computer literacy – familiar with MS Words and Excel.
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
-
Associate - Trial Capabilities
4 weeks 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 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-10
3 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 Researh Coordinator
7 days 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...
-
Associate, Rtr
4 weeks ago
Petaling Jaya, Malaysia Abbott Laboratories Full time**MAIN PURPOSE OF ROLE**: - The Associate, RTR will support divisions, legal entities and countries as assigned to gain, over time, a deep understanding of the various business divisions, and the unique attributes of the legal entity, regulatory, and in-country requirements associated with the region. **MAIN RESPONSIBILITIES**: **Service Delivery**: -...
-
Associate, RTR
3 weeks ago
Petaling Jaya, Malaysia Abbott Laboratories Full timePrimary Job FunctionThe Associate, RTR will support divisions, legal entities and countries as assigned to gain, over time, a deep understanding of the various business divisions, and the unique attributes of the legal entity, regulatory, and in-country requirements associated with the region. Main ResponsibilitiesService DeliveryIn-depth understanding of...
-
Legal Associate
4 weeks ago
Petaling Jaya, Malaysia NICK TAN & CO Full timeAttending case management, hearing and trial - Drafting cause papers and conducting case research - Managing client and other litigation-related legal work **Job Requirements**: - Min 1-2 years of experience in Litigation/ Criminal - Independent & resourceful, able to provide solution - Goal-oriented, complete assigned task on a timely manner - Good...
-
Site Contract Leader
4 weeks ago
Petaling Jaya, Malaysia Parexel Full timePetaling Jaya, Malaysia **Job ID** R0000015727 **Category** Clinical Trials **ABOUT THIS ROLE**: **Job Description**: **Key Accountabilities**: - Oversee the site contracting process for clinical trials, ensuring that contracts are executed in a timely and effective manner - Monitor, drive, and report on site contract performance throughout the whole...
-
Clinical research coordinator
6 days ago
Petaling Jaya, Malaysia Beacon Hospital Sdn Bhd Full time1. Primary point of contact to Sponsors and Contract Research Organisations (CRO) on enquiries related to clinical research.2. Prepare site and inform & remind team on any pre-qualification visit by Sponsor / CRO.3. Assist Investigators / Sub Investigators in preparation of required documents for ethics submission to Clinical Research Associate (CRA from...
-
Global Infrastructure
3 weeks ago
Petaling Jaya, Malaysia Danaher Full timeFind what drives you on a team with a more than 75-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve their toughest challenges. Our products serve diverse, global customer needs across a wide range of applications to...
-
Petaling Jaya, Malaysia KPMG Full timeAssociate - Indirect Tax (KDN ACDC) **Grade**: Graduate **Department**: KPMG Delivery Network **Descriptions**: The world of global advisory, audit and tax compliance services for large multi-nationals is rapidly changing and heavily dependent on technology. The KPMG Delivery Network (KDN) is a KPMG special purpose member firm offering a way for clients...
-
Associate, RTR
3 weeks ago
Subang Jaya, Selangor, Malaysia Abbott Laboratories Full timePrimary Job FunctionThe Associate, RTR will support divisions, legal entities and countries as assigned to gain, over time, a deep understanding of the various business divisions, and the unique attributes of the legal entity, regulatory, and in-country requirements associated with the region. Main ResponsibilitiesService DeliveryIn-depth understanding of...
-
Payroll Executive
4 weeks ago
Petaling Jaya, Malaysia Shopper360 Full time**Duties & Responsibilities** - Manage full cycle of payroll processing for the Shopper360 Sdn Bhd group of companies, ensuring accuracy and compliance with statutory requirements. - Handle new hires, register with EPF, notify tax authorities, and prepare necessary forms. - Facilitate confirmation of employment and monitor associates' employment status. -...
-
Payroll Executive
4 weeks ago
Petaling Jaya, Malaysia Shopper360 Sdn Bhd Full time**Payroll Executive (Job Descriptions)** - Manage full cycle of payroll processing for the Shopper360 Sdn Bhd group of companies, ensuring accuracy and compliance with statutory requirements. - Handle new hires, register with EPF, notify tax authorities, and prepare necessary forms. - Facilitate confirmation of employment and monitor associates' employment...
-
Clinical Specialist
4 weeks 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...
-
Associate Business Planning Analyst
4 weeks ago
Petaling Jaya, Malaysia IBM Full timeIntroduction At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. Are you ready to lead in this new era of technology and solve some of the world's most...
-
Sales Executive, Cmf
6 days ago
Petaling Jaya, Malaysia Johnson & Johnson Full time**Key Responsibilities**: - Helps establish and implement programs and innovative initiatives for the organization to advance Clinical Sales - Specialty Physicians initiatives. - Contributes to projects, programs, or processes for the Clinical Sales - Specialty Physicians area. - Integrates methods based on analyses of trends and the competitive landscape...
-
Teacher - Coordinator
4 weeks ago
Petaling Jaya, Malaysia P3 Platform Full time**Teacher - Assistant Coordinator** **Roles and Responsibilities** We are looking to recruit **Coordinator **to be the point of contact and work closely with person in charge of Curriculum from Schools & Learning Center. **The role**: This position reports to the Operation Manager and will also be supporting the key areas which will include, but not to be...
-
Study Tour Specialist
4 days ago
Subang Jaya, Malaysia AUG Student Services Full time**Development of Study Tour Program**: - To develop study tour programs that promote AUG’s partner institutions and study destinations - To research on destinations, venues, and activities that contribute to participants educational and cultural immersion. - To collaborate with partner education institutions on campus activities such as trial classes,...
-
Product Manager
4 weeks ago
Petaling Jaya, Malaysia B. Braun Medical Supplies Sdn. Bhd. Full timeManage the elements of the marketing mix for the designated and defined range of products to achieve the company's market share, profitability and strategic objectives in Malaysia and Brunei. **Duties and responsibilities**: - Develop, implement and evaluate marketing plans) and strategies for existing and new products. - Develop marketing,...
-
Procure to Pay
4 days ago
Petaling Jaya, Malaysia Matchlink Sdn Bhd Full timeROLES AND RESPONSIBILITIESTo ensure payments submitted via the ADEX System have proper documentation in accordance with the Procurement Procedures & Guidelines. All payments are to be reviewed in a timely manner and Vendor Invoices are to be recorded in the Accounting System correctly and without delay.To prepare payment batches in the bank portal for...