Sr. Clinical Project Manager

Location

Secunderabad | India

Job description

Responsible for Clinical execution and management of all aspects of assigned clinical studies (interventional and non-interventional, from early phase to late phase) and other clinical services (e.g. managed access programs (MAP), Research Collaborations, IITs, Digital Solutions etc. driven by GBS on behalf of Novartis Organizations.

Key Responsibilities:

• Lead a global study team responsible for the planning and implementation of all operational aspects of scientifically and operationally sophisticated studies from study concept to clinical study report/manuscript writing, according to timelines, budget, operational and quality standards (ICH/GCP/SOPs and procedures).
• Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) in the effective planning, regular re-evaluation and implementation of assigned clinical studies and/or MAP/Research Collaborations/IITs/Digital Solutions programs according to Novartis Global processes ensuring adherence to timelines, budget, quality standards and operational procedures. Might be required to lead other projects/program, in collaboration with cross-functional teams.
• Accountable for investigators meeting organization and all internal meetings related to the clinical study execution and operational excellence.
• As applicable, directly Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution in alignment with Novartis global standard and local regulatory requirement.
• As applicable support compilation of study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated CONEXTS, Novartis line functions and CRO Partners as required. Also if needed support clinical studies with all onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions.
• In partnership with Clinical Operations Specialists (COS) (where applicable) accountable for the set up and maintenance of the Trial Master File (TMF), Clinical Trial Management.
• Responsible for working with CTT and QA to identify potential issues and implementing actions to resolve them.
• Where applicable oversee the work of assigned Clinical Project Manager(s), Clinical Operations Specialists(s), ensuring clear delegation /assignment of duties are documented.
• Lead innovation by identifying areas for process or technology improvements and participate in continuous improvement initiatives.
• Act as a mentor, including support the training and onboarding of new associates.
• Developing a continuous process of learning and reflection and solution-orientated approach.
• Champion the implementation of operational changes and transitions as required.

Role Requirements

Essential Requirements

• Relevant educational background in life sciences/Healthcare (Ideally a Bachelor s Degree or above in life sciences) or equivalent combination of education, training and experience
• Approximately 10+ years of Clinical Operations experience with strong managerial experience in planning, driving, reporting and publishing clinical studies (interventional and non-interventional, early to late phase) in a pharmaceutical company or contract research organization.
• Proven ability to establish effective working relationship in a matrix and multicultural environment.
• Detailed knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.

Desirable Requirements:

• Project management skills and experience a plus.
• Strong technical and organizational skills (Excel, MP).

Job tags

Salary