Study Start Up Lead

Roche; Mumbai; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Roche recherche un Study Start Up Lead (SSUL) à Mumbai pour piloter les processus de démarrage d’études cliniques, en collaboration avec les équipes locales et globales. Le rôle exige une maîtrise des exigences réglementaires et une approche cross-fonctionnelle efficace afin d’assurer des démarrages de sites rapides et conformes.

Vous travaillerez dans un environnement international, en anglais et en langues locales, avec des partenaires externes et des comités d’éthique, pour garantir le bon

Qualifications

• Excellente communication et interfaces avec multiples parties prenantes.
• Bonne compréhension des exigences ICH-GCP et des cadres réglementaires locaux.
• Expérience en démarrage d’études cliniques et coordination cross-fonctionnelle.

Responsibilities

• Diriger la stratégie et l’exécution du start-up d’études au niveau pays et sites.
• Superviser les démarrages, assurer activation rapide et conformité réglementaire.
• Gérer les soumissions, amendements et coordination réglementaire des essais.
• Assurer la documentation des sites et le respect des exigences locales.
• Travailler avec CRO et partenaires pour harmoniser les systèmes et les délais.

Skills

Communication

Organisation

Analyse

Problème

Anglais

Education

Doctorat/MD/PhD ou équivalent en sciences de la vie

Tools

Veeva Vault

CTIS

RIM

Job description

Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

La position

Job Title: Study Start Up Lead (SSUL)
Location: Mumbai

Purpose, Objectives and Scope of Position

As a member of the PDG Country Study Start-Up Team, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff. Collaboration with local internal and external country teams, global study teams, and CROs is essential to this role.

Key Responsibilities

This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance.

Key responsibilities include

• . Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
• . Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.
• . Ensuring alignment with global strategies and timelines.
• . Managing amendments throughout the study lifecycle.
• . Identifying and driving opportunities for process automation, standardization, and innovation.
• . Collaborating with regional and global counterparts to harmonize systems and improve timelines.
• . Participating in external industry collaborations to influence country start-up environments.
• . Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities).

You will lead in a cross functional environment in multiple of the following areas below:

Study Start-Up Strategy & Execution

• . Lead teams in the creation of the study start-up strategy and execution of the study start-up process, encompassing strategy development, proactive risk mitigation, regulatory compliance, stakeholder liaison, tracking, knowledge management, and collaborative planning with CRO partners.

Informed Consent Form (ICF) Management

• . Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and best practices

Clinical Trial Submissions & Regulatory Coordination

• . Lead the development and oversight for clinical trial submissions, amendments and regulatory coordination, managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle.

Site Documentation & Compliance

• . Strategically manage site documentation and compliance, overseeing document collection/validation, coordination of related processes, and local vendor management (excluding CROs) if needed.
• . Oversee translation and approval of drug labels and patient-facing materials, as required
• . Maintain up-to-date knowledge of country-specific regulations, including those for medicinal products, medical devices, and IVDRs

Budgeting & Contract Management

• . Provide comprehensive strategic planning, oversight and implementation for all aspects of budgeting and contract management, including developing Fair Market Value-based budget strategies and drafting clinical site budgets, negotiating and implementing contracts, confidentiality disclosure agreements, indemnity/insurance documentation, and amendments, ensuring financial and legal alignment through collaboration with internal and external stakeholders, and maintaining accurate contract data in systems to support effective planning and forecasting

Payment Oversight

• . Strategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.

Qualifications

• . Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master’s degree highly desirable
• . Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration
• . Strong understanding of ICH-GCP, EU CTR, and local regulatory environments
• . Experience managing vendor/CRO relationships

Skills & Competencies

• . Excellent communication and interpersonal skills
• . Strong organizational, analytical, and problem-solving capabilities
• . Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.)
• . Collaborative and adaptable mindset with attention to detail
• . Ability to lead through complexity and ambiguity, especially in matrixed and global teams . Fluency in written and spoken English is mandatory. . Fluency in written and spoken language(s) of the host country is mandatory.

Qui nous sommes

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l'équité en matière d'emploi.