About the job

Job Description

145 ! Is the number of colleagues in clinical project management contributing to >100 diverse clinical projects across the entire Novartis organization. Come join this team of multi-cultural, motivated and solution-focused colleagues directly impacting the lives of patients and families.

Your responsibilities include, but are not limited to:

• Agree with Sponsor and GBS Line Functions on realistic trial timelines. Accountable for the writing of clinical protocols and related documents in collaboration with the GBS or Sponsor Medical representative as appropriate
• Lead the Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures.
• Accountable for investigators meeting organization and internal meetings related to the clinical trial execution. In collaboration with the GBS or Sponsor Medical representative, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation
• Ensure input is provided to clinical outsourcing specifications to facilitate selection of vendors. Accountable for project / trial allocation plans within given indications. Work closely with the Regional Monitoring Managers on feasibility and patient enrolment.
• 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.
• 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.
  
  

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Advanced degree or equivalent education/degree in life science/healthcare is required. 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.
• Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment. Good leadership, negotiation and project management skills
• Thorough knowledge of GCP, clinical trial design, statistics, regulatory processes, and global clinical development process. Demonstrated presentation skills.
• Strong customer oriented mindset. Ability to resolve issues with minimal supervision and understand when to escalate. Willingness to act accountably in project / trial management.

Apply through below link

Sr Clinical Project Manager | Novartis India | LinkedIn