Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Post: Clinical Project Administrator
Job Description:
Trial and Site administration:
1) Tracking (e.g. essential documents) and reporting,
2) Ensure collation and distribution of study tools and documents,
3) Update clinical trial databases (Spectrum),
4) Responsible for clinical supply & non-clinical supply management
Document Management:
1) Prepare documents and correspondence,
2) Collate, distribute, and archive clinical documents (i.e. TMF),
3) Updating manuals/documents (e.g., patient diaries, instructions),
4) Document proper destruction of clinical supplies.
Regulatory and Site startup Responsibilities
1) Provide to and collect from investigators forms/lists for site evaluation/validation and site start-up, 2) Preparation of submission package for IRB/ERC and support regulatory agencies submissions. Budgeting (may require to support)
Collaborate with finance/budgeting representatives for:
1) tracking, and reporting of negotiations
2) contract development, approval and maintenance,
3) payments (investigators, vendors, grants),
4) Monitor and track adherence and disclosures,
5) Budget closeout
Meeting and Planning
1) Organize meetings (create & track study memos/letters),
2) Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
Education/Qualifications:
Education/Qualifications : Science/Pharmacy degree preferred
1. ability to follow established processes/protocols and work together with manager to address problems.
2. ability to assess impact to changes in local regulations on existing processes to ensure continued compliance and or identify gaps in existing processes
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Experience:
* Minimum 6 months of clinical research administration experience
* Able to work independently
* Good planning, organization and problem solving skills.
* Good communication skills
* Fluent in local language and in English both written and verbal.
Additional Information:
Requisition ID:63035BR
Experience: Min 6 Months
Location: India
Education: degree in science/Pharmacy
Industry Type: Pharma/ Biotech/Clinical Research
Job Type: Clinical Research
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