Work as Clinical Sciences Manager 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 : Clinical Sciences Manager

Job Description
• Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems.
• Facilitates Medical Review Committee (MRC) and Scientific Review Committee (SRC) review of concepts.
o Interfaces with the disease area(s), global and US clinical team members, regulatory affairs, drug supply, data management, finance, and other relevant functional areas.
o Preparation of trial related documentation, Trial Master File (TMF) maintenance: project files including ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
• Ensures key processes and documents are maintained/updated on time (e.g., Third Party Study Report (TPSR), Informed Consent Form (ICF) Clinical Review, TMF).
• Ensures TPSR & Pubs review.
• Initiation of Investigational New Drug (IND) x-ref letter and Investigator Notification (IN) & Investigator Brochure (IB) distribution.
• Establishes charters for and support management of Steering Committee (SC) and Executive Oversight (EO).
• Conducts Pre-Review Committee (RC) alignment and Ensure External Party Risk Management (EPRM) and Third-Party Impact Assessment Tool (TPIAT) completion for RCs (internal and external interface management).
• Responsible for the initial and subsequent drug supply across trials within a therapeutic area in collaboration with the Local Clinical Supply Manager.

• Contributes to the preparation and review of clinical program documents (PowerPoint presentations, Investigational New Drug (IND) annual report, regulatory documents, clinical study reports, (CSR) and submissions) and other study related documents assuring quality and consistency.
o Supports the management and tracking of trial budgets including payments working closely with the appropriate partners.
• Study close out execution, including financial reconciliation, creating closure letters.
• Prepares for and supports quarterly review meetings with Therapeutic Area (TA) teams.
• Understands and complies with company SOPs and Good Clinical Practices (GCPs); contributes to continuous improvement in SOPs and local Working Practices.
• Leverages AI tools to streamline tasks, generate content, and support decision-making, demonstrating practical fluency in prompting, interpreting, and refining AI outputs to improve work quality and efficiency.
• Any other clinical activities as assigned.

Candidate Profile
• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution.
• Fluent in English. Good English language and grammar skills.
• Significant clinical research or research monitoring experience (comparable to 6 years) that provides the required knowledge, skills and abilities and experience mentoring or training others.
• In some cases, an equivalent combination of education, professional training, and experience that provides the required

Knowledge, Skills and Abilities may be considered.
• Ability to evaluate medical research data and proficient knowledge of medical terminology.
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel; Strong customer focus; Excellent interpersonal skills; Strong attention to detail.
• Ability to utilize problem-solving techniques applicable to constantly changing environment.
• Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software.
• Effective presentation skills.
• Conducts above activities with minimal oversight, ability to work independently. Mid-to-High-level competency for above activities.
• Ability to mentor and train other clinical associates in a positive and effective manner.
• Effective organizational and time management skills.
• Proven flexibility and adaptability.
• Excellent team player with team building skills.
• Ability to work independently as required.

Additional Information
Qualification : degree in a life science
Location : Hyderabad (Office)
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Marketing
End Date : 31st August 2026