Clinical Project Coordinator - Hyderabad, India - Makrocare
Description
Company DescriptionMakroCare |
_A MakroGroup Company_MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.- MakroCare is Certified with ISO 9001 (QMS), ISO ISMS), ISO ITSM), ISO Medical Device Clinical Investigations)
Job Description:
Clinical Project Coordinator
Job Overview:
- The primary responsibility of the Clinical Project Coordinator is to work with the Operations staff in coordinating clinical project activities.
- Assist with Project planning, including the development of timelines, resources, and budgets and facilitate the plan.
- Assist with the management of clinical programs, including personnel management and development, and effective delegation of assignments.
Responsibilities:
- Ensures work is performed in accordance with internal SOPs and working practices, industry guidelines, GCP, and other regulations.
- Coordinate with all functional groups (finance, clinical, medical, regulatory, IT, and legal) to identify, assess, and solve problems in order to assure project progress and timely completion of project goals.
- Effectively communicate (oral and/or written) projectrelated information including the planning and execution of meetings and presentations.
- Assist with project startup activities and throughout the life cycle of the project
- Schedule and coordinate site training and assist in the site qualification process
- Execute test scripts for studyrelated UATs
- Ensure timely updates to the project tracker
- Perform clinical data entry and verification tasks as needed
- Maintain TMF and ensure project documents are complete, current, and stored appropriately
- Report on project status to client and management; generate weekly status, site, and enrollment reports
- Schedule project meetings generate agendas and document meeting minutes
- Perform other duties as assigned by the supervisor
Eligibility Criteria:
- Selfmotivated and able to grasp new concepts and learn quickly
- Serviceoriented approach, flexible and proactive toward adapting to client needs
- Ability to manage project activities with diverse groups and individuals
- Must have superior attention to detail and excellent oral and written communication skills and the ability to excel in a team environment
- Excellent communication skills (both written and oral)
- Education must be in Life Sciences (B Pharmacy/M Pharmacy/Pharm D) only.
- Experience should be 6 Years
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