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Search for Jobs by Bharathi Nekkanti

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Site Manager-Oncology-NY/NJ (Healthcare & Medical)
NEW YORK, NY
Recruited by: Bharathi Nekkanti | Recruiter | DOCS See all my Jobs

  • Hiring Company: DOCS
  • Industry: Healthcare & Medical
  • Compensation: to be determined
  • Expires: Jan 29, 2020
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Job Description

Job Summary

DOCS clients include small, mid and large sized Pharmaceutical companies in addition to many leading Biotechnology, Medical Device and CROs. As a global partner, DOCS currently offers global resourcing solutions to our clients.

Roles & Responsibilities of the position

Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
Acts as primary local company contact for assigned sites for specific trials.
Attends/participates in investigator meetings as needed.
Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
Arranges for the appropriate destruction of clinical supplies
Ensures site staff complete the data entry and resolve queries within expected timelines.
Ensures accuracy, validity and completeness of data collected at trial sites
Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate.
Maintains complete, accurate and timely data and essential documents in systems utilized for trial management
Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
Complies with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities.
Prepares trial sites for close out, conduct final close out visit.
Negotiates investigator budgets at site level, if applicable.

Job Requirements

Four year degree required
Minimum 3+ years recent clinical monitoring required
Solid medical/science background required
Phase II/III experience
Experience in multiple Therapeutic Areas a plus
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Strong IT skills in appropriate software and company systems.
Willingness to travel 65% with frequent overnight stay
Live in or commutable distance to major city