*NEW* Clinical Trial Specialist (Office hours/Pharma MNC) -Good Progression
- Provide maintenance support to their assigned study teams, and may also provide support Seniors in the execution of Site Start Up activities.
- Assist in the creation and execution of contract amendments and drafts of confidentiality agreement or clinical trial agreements.
- Manage global site insurance certificate process and responsible for data base entry, contract repository and contract signature tracking.
- Manages set-up of new vendors and set-up of the site payment process.
- Perform all the roles encompassed in the preceding grade levels within the job family as required by the organization.
- Conduct work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures.
Clinical Trial Agreement (CTA) management
- Draft and maintain study specific CTA templates
- Coordinate the tracking, execution and scanning / uploading of CTA/Amendments for contract managers across all offices
- Develop, draft and negotiate CTA amendments within established study budgets
- Assist and manage the Data Driven Payment process for assigned studies
- Manage issuance, execution and tracking of insurance certificates for global clinical studies
- Data entry and uploading of documents to appropriate portals and repositories
- Attend and participate in CTA finalization and start-up meetings
- Answer questions and resolve problems concerning all assigned studies and individual contracts
- Track workflow and contract costs for assigned studies and individual contracts
- Ensure contracts are executed within fair market value (FMV) standards as appropriate
- Ensure contracts are executed in compliance with applicable SOP’s and policy.
- Directly manages clinical essential document maintenance and close-out activities for clinical sites, and may also assist more senior Start Up Representatives with start-up activities for their assigned trials. Activities include but are not limited to: Customization of clinical study informed consent forms and patient privacy authorization forms adapted to IRB-specify formats. Management of amendments, support of assigned start up activities.
- Min BA/BS Degree in Business or Life Sciences
- Basic understanding of Good Clinical Practices, ICH guidelines, PhRMA code, clinical research ethics, and patient privacy laws (plus applicable local regulations, when country-based).
- Basic skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook,
- Training is provided
Interested candidates please send a copy of your resume to estherlim@ recruitexpress.com.sg
Email Subject: Clinical Trials Specialist – Esther
Esther Lim Suk Hui
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
Recruit Express Pte Ltd