Urgent Opening- Senior Clinical Research Associate
Wockhardt Limited
5 - 10 yrs
Mumbai
Job Description
- Acts as the main line of communication between the sponsor and the investigator. Responsible for site relationships for the assigned sites.
- Prioritize work effectively and ensure all tasks are completed on time and with high quality, in accordance with company policies, ICH-GCP and regulations.
- Effectively multi task various site related functions across all assigned sites such as: feasibility, investigator selection, Monitoring , follow-up with site for trial update, collaborate with site for patient recruitment strategies, safety reporting etc.
- Play an important part in site team training. Identify training needs and facilitate the training of sites with help of Clinical Project Manager (CPM) and Clinical Team Lead (CTL).
- Ensure complete support to internal study teams to ensure completion of team commitments on the trial deliverables including (not restricted to) ethics committee submissions, investigator/coordinator meetings, execution of site level budgets.
- Perform Site Selection, Initiation, Monitoring and Close-out visit as per Monitoring Plan and complete the visit reports within 7 working days.
- Validate the consistency between the source and data captured on the CRFs to ensure credible and quality data is generated from the site.
- Open and clear communicator and a good listener.
- Recognize recurring issues and analyze their causes in order to achieve accurate and timely results
- Professional, team player, self-starter, effective stakeholder management skills. Good at time management and has a flair for getting work done.
- Identifies problems and approaches them logically
- Resolves issues in timely and appropriate manner and escalates as necessary.
- Strong organizational skills with attention to details. Is open, adaptable, and resilient to change without compromising self or organizational values, takes responsibility for own actions
If the above criteria matches with your profile then please email your updated CV at hsevekar@wockhardt.com
Company Profile:
Wockhardt Limited
Wockhardt is a true Indian Multi-National Company with a multi-ethnic workforce of 8600 Associates from 21 different nationalities globally. We have 3 research centers and 12 manufacturing plants, with businesses ranging from the manufacturing and marketing of Pharmaceutical and Bio-pharmaceutical formulations, Active Pharmaceutical Ingredients (APIs) and Vaccines. The company has successfully created an integrated multi-technology capability to manufacture all types of dosage forms including sterile injectables and lyophilized products. Highly skilled technicians operate 12 manufacturing facilities that are US FDA, UK MHRA and EMEA compliant sites in India, the US and Europe.Â
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