Specialist - 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 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 Specialist role provides technical support to clinical trial capabilities team in support of clinical development. The Specialist is responsible for activities related to study start-up (SSU) and investigator site's readiness for patient enrollment, maintenance and close out. The Specialist will ensure inspection readiness through a complete, accurate and readily available Trial Master File.

**Responsibilities**:

- Track site compliance to required training to effectively drive timelines aligned with company priorities.
- Manage/coordinate clinical trial system account request for investigator sites, as applicable.
- Identify, communicate, and resolve issues.
- Accountable for accurate and complete data entry of clinical trial information into various clinical trial systems, including maintaining systems and local tracking tools to allow tracking, performance metrics reporting and to meet Lilly and regulatory compliance requirements.
- Support inspection readiness through a complete, accurate and readily available Trial Master File including performing quality review periodically on documents related to Trial Capabilities.
- Anticipate and monitor dynamically changing priorities
- Understand, comply, and reinforce local regulations and guidance, Lilly medical policies and procedures, and good clinical practices (GCP)

**Minimum Qualification Requirements**
- A diploma/degree or equivalent, preferably in a scientific or health related field
- Clinical research experience or relevant experience preferred
- Applied knowledge of project management processes and skills
- Appreciation of/experience in compliance-driven environment
- Ability to learn and comply with regulatory requirements, and internal policies.
- Effective communication, teamwork and problem-solving skills; good attention to details and accuracy; 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



  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • Petaling Jaya, Malaysia AGENSI PEKERJAAN ICONIC MALAYSIA GW SDN.BHD. 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...


  • Petaling Jaya, Malaysia Parexel Full time

    Petaling Jaya, Selangor, Malaysia **Job ID** R0000023324 **Category** Clinical Trials **ABOUT THIS ROLE**: The feasibility specialist plays a crucial role in the Strategic Feasibility department in the following: 1)** Preaward proposals and bid pursuit meetings**:Supporting data analysis, site list generation and site level visualizations for proposal...

  • Senior Specialist

    4 weeks ago


    Subang Jaya, Selangor, Malaysia MSD Full time

    Merck & Co., Inc. seeks a SAC-P COE Sr. Specialist to oversee SAC planning work streams, design data models, and implement analytics technologies. The role requires expertise in SAC, Datasphere, SAP BW, HANA, Master Data management, and ECC, as well as proficiency in MS Excel, Word, and PowerPoint. The ideal candidate will have a Bachelor's degree in...


  • 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 Specialist

    5 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...

  • Senior Specialist

    4 weeks ago


    Petaling Jaya, Malaysia MSD Full time

    Job DescriptionPosition OverviewWithin the Global Business Solutions (GBS) organization, the incumbent is responsible for ensuring the SAC-P COE operations activities in the forecasting cycle for FP&A teams appropriately to optimize business transactions. The incumbent will also provide operations solutions reviewing and analyzing system and passive data...

  • Product Specialist

    5 months ago


    Petaling Jaya, Malaysia TruVisor Malaysia Full time

    **Company Description** TruVisor is a visionary distributor with cloud and managed services capabilities. We offer solutions that focus on Automation & Cybersecurity technologies for our channel partners. **Role Description** This is a full-time hybrid role as a Product Specialist at Truvisor.io. The Product Specialist will be responsible for various...


  • Petaling Jaya, Selangor, Malaysia SummitNext Technologies Sdn Bhd Full time

    Job Summary:We are seeking a skilled Risk Management Specialist to join our team at SummitNext Technologies Sdn Bhd. As a Risk Management Specialist FX, you will play a crucial role in implementing risk management processes for the organization.Key Responsibilities:Implementing risk management processes for the organizationAssisting in preparing various...


  • Petaling Jaya, Selangor, Malaysia SummitNext Technologies Sdn Bhd Full time

    At SummitNext Technologies Sdn Bhd, we are seeking a skilled Risk Management Specialist to join our team. The ideal candidate will have a strong background in risk management and be able to implement effective processes to mitigate potential risks.Key Responsibilities:Develop and implement risk management strategies to ensure the company's financial...

  • Product Specialist

    5 months ago


    Petaling Jaya, Malaysia FRONIX SDN BHD Full time

    We are seeking a dynamic and experienced Product Specialist to join our team in the information technology industry. The Product Specialist will play a crucial role in supporting our sales team by providing technical expertise and solutions to meet the needs of our clients. This position requires a deep understanding of IT infrastructure products such as...


  • Petaling Jaya, Malaysia IKEA Full time

    **Job ID**: REF5451R **Date posted**: 03/09/2024 **Company description** IKEA is the world’s largest home furnishing retailer with 460 stores across more than 60 countries. IKEA Malaysia is part of Ikano Retail, one of 12 IKEA franchisees and the only one owned by the family of Ingvar Kamprad, who founded IKEA in 1943. IKEA Malaysia creates a better...

  • Key Account Specialist

    5 months ago


    Petaling Jaya, Malaysia Abbott Laboratories Full time

    **MAIN PURPOSE OF ROLE** - To assure consistent sales growth and achievement of sales goals and targets in an assigned territory by identifying opportunities and gaining new business while maintaining existing business. **MAIN RESPONSIBILITIES** - To promote Abbott range of EPD products to healthcare professionals in an assigned territory. - To make...


  • Petaling Jaya, Malaysia FrieslandCampina Full time

    FrieslandCampina IT has defined its strategy, including strategic priorities and supporting programs, it is essential that the strategy is known and understood within the organization. Furthermore effective change management is critical in the success of many IT / Process related projects (system implementations, process optimizations, etc.) The Change &...


  • Petaling Jaya, Selangor, Malaysia SummitNext Technologies Sdn Bhd Full time

    At SummitNext Technologies Sdn Bhd, we're looking for a skilled Risk Management Specialist to join our team. This role plays a crucial part in ensuring the stability and reliability of our trading platform.Key Responsibilities:Implement risk management processes to safeguard our organization's interestsAssist in preparing trade reports and analyzing...

  • Key Account Specialist

    5 months ago


    Petaling Jaya, Malaysia Abbott Laboratories Full time

    **_MAIN PURPOSE OF ROLE_** - To assure consistent sales growth and achievement of sales goals and targets in an assigned territory by identifying opportunities and gaining new business while maintaining existing business. **_ MAIN RESPONSIBILITIES_** - To promote Abbott range of EPD products to Pharmacies in an assigned territory. - To make effective use of...