Clinical Study Manager

F. Hoffmann-La Roche AG; Mumbai; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

A Roche está recrutando um Clinical Study Manager (local studies) em Mumbai para liderar equipes locais e a entrega operacional de estudos clínicos em todas as fases, assegurando conformidade com padrões de qualidade e regulamentos indianos. O papel envolve interação com equipes globais, CROs e sites, mantendo prazos, orçamento e qualidade.

O candidato ideal possui formação universitária na área médica ou ciências, com experiência em operações clínicas, gestão de fornecedores e conhecimento de

Qualifications

• Conhecimento de ICH-GCP e regulamentos indianos aplicáveis.
• Experiência em operações clínicas e gestão de fornecedores.
• Formação universitária em área médica/ciência ligada à função.

Responsibilities

• Liderar a equipe de estudo local e planejamento estratégico.
• Garantir entrega operacional de estudos clínicos locais dentro de prazos e orçamento.
• Supervisionar relação com CROs, sites e parceiros, mantendo conformidade.
• Participar na preparação de documentos regulatórios e QA/inspeções.

Skills

ICH-GCP knowledge

Indian Regulations

Clinical Operations

Vendor Management

Education

University degree or equivalent

Pharmaceutical medicine training desirable

Job description

Clinical Study Manager### Clinical Study ManagerCandidatar-se: Mumbai: Tempo integral: Publicado hoje: Data de término: 13 de novembro de 2026 (12 dias restantes para se candidatar): 202610-127502Na Roche, você pode-se apresentar como você mesmo, abraçado pelas qualidades únicas que traz. Nossa cultura incentiva a expressão pessoal, o diálogo aberto e as conexões genuínas, onde você é valorizado e respeitado por quem você é, e permitindo que você prospere tanto pessoal como profissionalmente. É assim que pretendemos prevenir, deter e curar doenças e garantir que todos tenham acesso aos cuidados de saúde hoje e nas gerações futuras. Junte-se à Roche, onde cada voz é importante.### A posição**Job Title: Clinical Study manager- local studies****Location:** (HO) Mumbai **Role Summary:** Provides leadership to study team, local strategic planning and operational delivery of assigned local clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with Roche quality standards, all applicable regulations, timelines and budget commitments. **How does the role serve the patients?*** Provides hands-on experience to KOLs on Innovative treatment through local phase 4, non-interventional studies, Investigator initiated studies, Real world evidence generation, Compassionate use program, Post trial access program.* By providing early access to innovative treatment to Indian patients.* By generating robust safety as well as efficacy data on Indian patients through participation in the clinical trials which in turn facilitates regulatory approvals for Roche Innovative products. **Accountabilities**Has full accountability and oversight for all assigned studies at country level (local studies) in accordance with the overall project plan, manages and maintains accurate study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate Roche planning system.* Leads local study teams, represents Country /Region Clinical Operations at the global SMT, and provides global teams with feedback from an Affiliate perspective* Works with relevant global study team to manage day to day activities of the study, including monitoring report review, problem solving, issues escalation , timely closure of non-productive studies and tracking of safety procedures* Plans and executes country study goals and commitments, and ensures compliance to relevant processes, Roche quality and safety standards, regulations, timelines and budget commitments.* Provides operational oversight of Investigator-initiated studies and Compassionate Use studies in terms of Roche quality and safety standards, regulations, timelines and budget allocation.* Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.* Coaches and provides support to responsible study team members by maintaining effective communication* Provides study oversight, leadership and support to Clinical Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.* Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies (including translations, as applicable)* Provides inputs to and/or develops study related materials such as Monitoring plans, recruitment plans and study Newsletters* Supports/coordinates the negotiation of site budgets within Fair Market Value guideline, budget plans and provide oversight for site payments as per contract, as required.* Participates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.* Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future Roche studies.* Participates in overall therapeutic area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required.* Performs/coordinates for Health Authority presentation for the study/protocol amendments.* For Local Studies, provides the leadership and clinical operations expertise for the local study team.**Internal Stakeholders**All Medical functions, Procurement, Legal, Finance**External Stakeholders**HCPs and HCOs, Regulatory authorities, Industry Bodies, Patient Support Groups and Vendors **Functional Competencies**Knowledge of ICH-GCP, Indian Regulations, multiple therapy area knowledge, technical expertise in the field of clinical operation, vendor management **Behavioral Competencies**Exhibition of Roche Core Values, Exhibition of Servant Leadership, Patient centricity in decision making, Strong Collaboration and Networking skills, Inspiring and Influencing **Eligibility Criteria (Qualification and Experience)*** University degree or equivalent; professional qualification preferably in a medical/science related field Pharmaceutical medicine training highly desirable* Higher degree and / or specialist accreditation desirable* Employee has completed **minimum 1 year** with Roche Pharma (Applicable for internal hire)* Employee having an overall experience of minimum 5 years in Pharmaceutical / Biotech / Clinical Research industry with minimum 5 years in Clinical Operations.* Clinical operations and quality assurance* **Job Location: Mumbai (HO)*** Willingness to relocate