*NEW* Clinical Trial Specialist (Office hours/Pharma MNC) -Good Progression

Recruit Express Pte Ltd| Date Posted: 6-Mar-2020
EA Licence No: 99C4599|EA Personal Registration No: R1872808
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Job Nature:
Permanent, Contract
Position Level:
Entry Level, Student Job
Qualification:
Bachelor's / Honours

Job Description

Responsibilities

  • 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.

Requirements

  • 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
R1872808
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

 

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Recruit Express Pte Ltd