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 : Sr Clinical Project Manager
Job Description
1. Agree with Sponsor and GBS Line Functions on realistic trial timelines.
2. Accountable for the writing of clinical protocols and related documents in collaboration with the GBS or Sponsor Medical representative as appropriate
3. Lead the Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational proce-dures.
4. Accountable for investigators meeting organization and internal meetings related to the clinical trial execution
5. In collaboration with the GBS or Sponsor Medical representative, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation
6. Ensure input is provided to clinical outsourcing specifications to facilitate selection of vendors
7. Accountable for project / trial allocation plans within given indications. Work closely with the Regional Monitoring Managers on feasibility and patient enrolment.
8. Work with GBS Line Functions and QA to identify potential quality issues and implement actions to resolve them. Work with GBS Clinical Data Sciences team to ensure timely availability of reports needed to track trial performance.
9. Accountable for the development, management and tracking of trial budget working closely with the GBS Finance and Sponsor representative. Accountable for accuracy of trial information in all trial databases and tracking systems.
1. Agree with Sponsor and GBS Line Functions on realistic trial timelines.
2. Accountable for the writing of clinical protocols and related documents in collaboration with the GBS or Sponsor Medical representative as appropriate
3. Lead the Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational proce-dures.
4. Accountable for investigators meeting organization and internal meetings related to the clinical trial execution
5. In collaboration with the GBS or Sponsor Medical representative, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation
6. Ensure input is provided to clinical outsourcing specifications to facilitate selection of vendors
7. Accountable for project / trial allocation plans within given indications. Work closely with the Regional Monitoring Managers on feasibility and patient enrolment.
8. Work with GBS Line Functions and QA to identify potential quality issues and implement actions to resolve them. Work with GBS Clinical Data Sciences team to ensure timely availability of reports needed to track trial performance.
9. Accountable for the development, management and tracking of trial budget working closely with the GBS Finance and Sponsor representative. Accountable for accuracy of trial information in all trial databases and tracking systems.
Candidate Profile
Advanced degree or equivalent education/degree in life science/healthcare is required. Fluent English (oral and written).
1. 10+ years’ Clinical Operations experience with at least 7 years managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
2. Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment
3. Good leadership, negotiation and project management skills
4. Thorough knowledge of GCP, clinical trial design, statistics, regulatory processes, and global clinical development process.
5. Demonstrated presentation skills.
6. Strong customer oriented mindset
7. Ability to resolve issues with minimal supervision and understand when to escalate.
8. Willingness to act accountably in project / trial management
Advanced degree or equivalent education/degree in life science/healthcare is required. Fluent English (oral and written).
1. 10+ years’ Clinical Operations experience with at least 7 years managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
2. Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment
3. Good leadership, negotiation and project management skills
4. Thorough knowledge of GCP, clinical trial design, statistics, regulatory processes, and global clinical development process.
5. Demonstrated presentation skills.
6. Strong customer oriented mindset
7. Ability to resolve issues with minimal supervision and understand when to escalate.
8. Willingness to act accountably in project / trial management
Additional Information
Experience : 7 years
Qualification : M.Sc, B.Sc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th April, 2019
Experience : 7 years
Qualification : M.Sc, B.Sc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th April, 2019
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