Specialist - Trial Capabilities
1 week ago
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 compliancedriven environment
- Ability to learn and comply with regulatory requirements, and internal policies.
- Effective communication, teamwork and problemsolving skills; good attention to details and accuracy; selfmanagement 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.
-
Trial Capabilities Manager
1 week ago
Subang Jaya, Selangor, 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...
-
Trial Capabilities Assistant-10
1 week ago
Subang Jaya, Selangor, 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
1 week ago
Subang Jaya, Selangor, Malaysia Agensi Pekerjaan & Perundingcara Bright Prospect Sdn Bhd Full timeTo 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
1 week ago
Subang Jaya, Selangor, Malaysia Manpower Group Malaysia Full timeMinimum 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...
-
Local Trial Manager, Global Clinical Operations
1 month ago
Subang Jaya, Selangor, Malaysia Johnson & Johnson Full timeJohnson & 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
4 weeks ago
Subang Jaya, Selangor, Malaysia Johnson & Johnson Full timeJohnson & 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
1 week ago
Subang Jaya, Selangor, Malaysia AGENSI PEKERJAAN ICONIC MALAYSIA GW SDN. Full timeManage 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...
-
Feasibility Specialist I
1 week ago
Subang Jaya, Selangor, Malaysia Parexel Full timeThe feasibility specialist plays a crucial role in the global Strategic Feasibility department in the following:Coordination of global standalone feasibility projects: Support the feasibility strategy leader in standalone feasibility to coordinate project system set up and maintenance, survey management, project finance management, survey result analysis and...
-
Feasibility Specialist I
3 weeks ago
Subang Jaya, Selangor, Malaysia Parexel Full timeThe feasibility specialist plays a crucial role in the global Strategic Feasibility department in the following:Coordination of global standalone feasibility projects: Support the feasibility strategy leader in standalone feasibility to coordinate project system set up and maintenance, survey management, project finance management, survey result analysis and...
-
Feasibility Specialist I
1 week ago
Subang Jaya, Selangor, Malaysia Parexel Full timePetaling Jaya, Selangor, MalaysiaJob ID R Category Clinical TrialsABOUT 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 slides. Support conduct of augmented...
-
57907212 cloud infrastructure specialist
1 week ago
Subang Jaya, Selangor, Malaysia half the sky Full timeCognizant is seeking a Cloud Infrastructure Specialist to join us in Kuala Lumpur. In this role, you'll build, implement, and operate IT solutions based on various vibrant technologies such as virtualization, container, JEE-based middleware, API gateway, cloud, APM and big data. As a Cloud Infrastructure Specialist, you will also be a key technical...
-
Clinical Researh Coordinator
1 week ago
Subang Jaya, Selangor, Malaysia RF Staffing and Outsourcing Solutions Sdn. Bhd. Full timeResponsibilities: 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...
-
Product Specialist
3 days ago
Subang Jaya, Selangor, Malaysia Monroe Consulting Group Full timeExecutive recruitment company Monroe Consulting Group Malaysia is recruiting on behalf of a leading provider of medical devices and life science equipment across Asia. Our distinguished client is looking for an experienced Product Specialist to drive product development and marketing of their analytical chemistry division in the company. Job...
-
Packaging Specialist Manager
1 week ago
Subang Jaya, Selangor, Malaysia Nestle Operational Services Worldwide SA Full timePosition SnapshotLocation: Batu Tiga Factory, Shah AlamCompany: Nestlé Manufacturing (M) Sdn BhdPermanent - Full TimeBachelor's Degree in Mechanical Engineering or any other engineering discipline5+ years of experiencePosition SummaryJoining Nestlé means you are joining the largest Food and Beverage Company in the world. At our very core, we are a human...
-
Product Specialist
1 week ago
Subang Jaya, Selangor, Malaysia TruVisor Malaysia Full timeCompany DescriptionTruVisor is a visionary distributor with cloud and managed services capabilities. We offer solutions that focus on Automation & Cybersecurity technologies for our channel partners.Role DescriptionThis is a full-time hybrid role as a Product Specialist at The Product Specialist will be responsible for various day-to-day tasks, including...
-
Commodity specialist
1 month ago
Subang Jaya, Selangor, Malaysia Sensata Technologies Full timeThe Commodity Specialist will be responsible for sourcing excellence and identifying cost reduction opportunities with a strategic mindset and approach. This role offers high visibility and tremendous growth potential within In-Direct Procurement, focusing on global commodities alongside key stakeholders, including top-level company executives.Participates...
-
Product Specialist
1 day ago
Subang Jaya, Selangor, Malaysia Monroe Consulting Group Full timeExecutive recruitment company Monroe Consulting Group Malaysia is recruiting on behalf of a leading provider of medical devices and life science equipment across Asia. Our distinguished client is looking for an experienced Product Specialist to drive product development and marketing of their clinical diagnostics division in the company.Job...
-
Brand Partner Specialist
1 week ago
Subang Jaya, Selangor, Malaysia IBM Full timeIntroductionTechnology sales at IBM is evolving it's way of working to break beyond boundaries with innovative approaches. Preferring to 'show' vs. 'tell', Client Engineering co-creates with prospective customers, in real-time, on solutions to their hardest business challenges.As a Cloud Engineer (what we in IBM call a 'Technology Engineer') within Client...
-
Technical Training Specialist
1 week ago
Subang Jaya, Selangor, Malaysia Otis Full timeDate Posted:Country:MalaysiaLocation:Otis Elevator Company (M) Sdn Bhd, 15-01 Menara Symphony, No 5, Jalan Semangat, Seksyen 13, 46200 Petaling Jaya, Selangor Darul Ehsan, MalaysiaAbout the roleThe Technical Training Specialist will play a critical role in supporting our technical training and development initiatives for our field operations team. This role...
-
Ecosystem Technical Enablement Specialist
1 week ago
Subang Jaya, Selangor, Malaysia IBM Full timeIntroductionAt 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...