Clinical Research Specialist

2 weeks ago

Petaling Jaya, Malaysia Eli 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 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 Research Specialist provides clinical trial capabilities in support of clinical development. The Specialist 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 Specialist is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, records management and site training. The Specialist 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
- Populate internal clinical trial systems ( e.g. IMPACT, Vault Clinical, Shared Investigator Platform ) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements
- Ensure complete, accurate and readily available Trial Master F ile

**Minimum Qualification Requirements**:

- Bachelor’s degree preferably in a scientific or health related field
- Four (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 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.

  • clinic reception

    2 weeks ago

    Petaling Jaya, Selangor, Malaysia Eternity Specialist Dental Full time 24,000 - 30,000 per year

    Job Title: Clinic Reception & Admin ExecutiveAbout UsEternity Specialist Dental Clinic in Kota Damansara is a modern, digital dental practice dedicated to creating confident smiles and delivering excellent patient care. We are looking for a friendly, reliable, and organized Clinic Reception & Admin Executive to join our growing team.Role OverviewYou will be...

  • Clinical Sales Specialist

    2 weeks ago

    Petaling Jaya, Selangor, Malaysia SPD Scientific Full time $70,000 - $120,000 per year

    Shape the Future of Health with Biomedia HoldingsJoin a leading life sciences group driving innovation inMicrobiology,Oncology, andInfectious Diseasesacross Southeast Asia. Headquartered in Singapore, Biomedia Holdings empowers healthcare, research, and pharma sectors with cutting-edge diagnostics, therapeutics, and lab technologies.As we expand across the...

  • Senior Quality Assurance Lead

    2 weeks ago

    Petaling Jaya, Selangor, Malaysia Emerald Clinical Full time

    AtEmerald Clinical Trials, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from...

  • Clinical Research Associate I

    1 week ago

    Petaling Jaya, Malaysia Parexel Full time

    Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction. As a CRA...

  • AI Research Scientist

    2 weeks ago

    Subang Jaya, Selangor, Malaysia Cancer Research Malaysia Full time $90,000 - $120,000 per year

    ABOUT THE ROLEWe are seeking a highly motivated and creativeAI Research Scientistto lead the development and improvement of AI models focused onoral lesion detectionas part of the MeMoSA (Mobile Mouth Screening Anywhere) project. This role is pivotal in advancing our institution's work in medical AI and setting the foundation for building a dedicated...

  • Clinical Research Analyst

    2 weeks ago

    Petaling Jaya, Malaysia Beacon Hospital Sdn Bhd Full time

    1. Plan and managing the types of information collected from patients, healthcare providers and medical researchers from Beacon Hospital 2. Provide support to the clinical research department on analytics execution 3. Manage and processing the raw datasets and conducted statistical analysis. Data sources include medical and pharmacy claims data, hospital...

  • Clinical Sales Specialist

    2 weeks ago

    Petaling Jaya, Selangor, Malaysia SPD Scientific (M) Sdn Bhd Full time 80,000 - 120,000 per year

    SPD Scientific (M) Sdn Bhd is recruiting We are located in Selangor, and we invite dynamic individuals to join us to grow the company to the next level for mutual success.We are recruiting for a Clinical Sales Specialist, preferably with experience in nursing, clinical support, and/or sales of medical devices in the operating theatre. This role will serve as...

  • Clinical Specialist

    2 weeks ago

    Petaling Jaya, Selangor, Malaysia Solventum Full time 120,000 - 240,000 per year

    Clinical Specialist3M Healthcare is now SolventumAt Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives...

  • Clinical Trial Psych Rater

    3 days ago

    Petaling Jaya, Malaysia IQVIA Full time

    **Clinical Specialist Consultant - Malay Speaking** **Location**:Remote/virtual** **Hours**:Estimated 10-16h/month** **Role**:Clinical Specialist** **Job Description**: The Clinical Specialist reviews scales administered by raters in a clinical trial to ensure that assessments are being conducted in a standardized manner to ensure data reliability. The...

  • Clinical Research Analyst

    2 weeks ago

    Petaling Jaya, Selangor, Malaysia Beacon TCM Full time 26,400 - 34,800 per year

    Plan and managing the types of information collected from patients, healthcare providers and medical researchers from Beacon HospitalProvide support to the clinical research department on analytics executionManage and processing the raw datasets and conducted statistical analysis. Data sources include medical and pharmacy claims data, hospital data,...