Job for Associate Clinical Operations Specialist at Novartis

Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Associate Clinical Operations Specialist

Job Description
1. Responsible for the set-up and maintenance of trial(s) in Clinical Trial Management Systems: Update data, timelines, milestones, EC/HA authorizations, etc. for Countries and Sites on an ongoing basis. Coordinate with CRO CRAs to obtain the Monitoring Visit dates and trip reports data in required templates and ensure that the data is updated in CTMS.
2. Coordinate with CRO CRAs to ensure readiness of Sites for initiation and upload all required documents into Document Management System (CREDI)
3. Responsible for ensuring all key documents are present and filed as appropriate in Trial Master File (TMF): Customize the country level TMF TOC (table of contents) and prepare TMF TOC for site level and ensure all the documents are uploaded / maintained in country level and site level TMF. Follow up with CRO CRAs at agreed frequency for countries and sites TMF documents. Follow TMF oversight plan and develop/ maintain appropriate documentation.
4. Support in Vendors and country coordination: Support CPM in collecting key trial information from external vendors and countries involved in trial execution. Ensure all data is reported to the Clinical Trial Team and in the Novartis databases (CTMS, CREDI) and available to customer. As required set up study related meetings and follow up with meeting minutes.
5. Track trial progress up to site and country level, ensure CTMS is up to date, report to customer as per scope of work. Address questions; escalate issues or critical findings to project lead (Sr./CPM).

Candidate Profile
Life Science degree or equivalent. Fluent English (oral and written).
1. At least 2-3 years’ operational experience of clinical study coordination in a pharmaceutical company or contract research organization.
2. Good technical and organizational skills (Excel, PowerPoint)
3. Details oriented.
4. Thorough knowledge of Good Clinical practice.
5. Ability to establish effective working relationship in a matrix and multicultural environment.
6. Presentation and diplomacy skills.
7. Strong customer oriented mindset.
8. Willingness to act accountably in project/trial management.

Additional Information
Experience : 2-3 years
Qualification : Life Science degree or equivalent
Location : Hyderabad, AP
Industry Type : Pharma
Functional Area : R&D
End Date : 25th May, 2019