Manager: Clinical Research & Operations

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Company: Swati Spentose Pvt. Ltd.
Department: Clinical Research
Designation: Manager Clinical Research & Clinical Operations
Experience: 3-6 years
Location: Mumbai

Reporting To: Head Clinical Research

Swati Spentose is looking for an experienced Manager Clinical Research & Clinical Operations to lead and manage the company's clinical research activities and provide end-to-end operational oversight of clinical trials.

The candidate will be responsible for planning, initiating, executing and closing clinical trials, while ensuring compliance with applicable regulatory requirements, ICH-GCP, study protocols and company SOPs.

The role will involve significant interaction with CROs, investigators, clinical sites, CRAs, vendors and internal cross-functional teams. The individual will also be responsible for clinical trial budgets, vendor negotiations, timelines, study quality and operational delivery.

We are looking for a hands-on clinical research professional who has progressed through roles such as CRA, CRC, Clinical Trial Manager or Clinical Project Manager and is ready to take ownership of clinical research operations.

Key Responsibilities

1. Clinical Trial Planning & Execution

• Lead clinical trials from study start-up through study close-out.
• Develop and manage study plans, timelines, milestones and operational deliverables.
• Coordinate site feasibility, site selection, activation and initiation activities.
• Oversee patient recruitment, retention and site performance.
• Monitor study progress and ensure timely achievement of clinical milestones.
• Identify operational challenges and implement appropriate corrective and preventive actions.
• Ensure smooth coordination between clinical sites, CROs and internal teams.

2. CRO & Clinical Site Management

• Identify, evaluate and oversee CROs and other clinical research vendors.
• Manage relationships with investigators, hospitals, clinical sites and study teams.
• Review CRO proposals, work scopes and study plans.
• Monitor CRO performance against agreed timelines, quality standards and deliverables.
• Review monitoring reports and follow up on site-level issues.
• Ensure timely resolution of site and study-related issues.

3. Clinical Trial Budget & Contract Negotiation

• Develop and manage clinical trial budgets.
• Review CRO and vendor commercial proposals.
• Negotiate CRO, investigator and site budgets.
• Review contracts, payment milestones, change orders and additional cost requests.
• Monitor study expenditure against approved budgets.
• Work closely with Finance, Procurement and Legal teams for contracts and payments.
• Identify opportunities for effective cost management without compromising study quality or compliance.

4. GCP & Regulatory Compliance

• Ensure clinical studies are conducted in accordance with:
• ICH-GCP
• Applicable regulatory requirements
• Approved clinical trial protocols
• Ethics Committee/IRB requirements
• Company SOPs and quality standards
• Ensure appropriate maintenance of essential clinical trial documentation and TMF.
• Support regulatory and Ethics Committee submissions where required.
• Support audit and inspection readiness.
• Ensure appropriate tracking and resolution of protocol deviations and quality issues.

5. Clinical Team Leadership

• Coordinate and lead cross-functional clinical trial teams.
• Work closely with Medical, Regulatory Affairs, Pharmacovigilance, Quality Assurance, Data Management and other relevant functions.
• Guide and supervise CRAs, clinical research associates/coordinators and external study teams as applicable.
• Conduct regular study review meetings.
• Track action items, risks, timelines and deliverables.

6. Study Monitoring & Reporting

• Review overall study performance and key operational metrics.
• Track:
• Site activation
• Patient recruitment
• Patient retention
• Monitoring status
• Protocol deviations
• Data/documentation status
• Study timelines
• Budget utilization
• Prepare periodic clinical trial status reports for senior management.
• Escalate critical operational, financial or quality risks in a timely manner.

7. Vendor & Stakeholder Management

• Maintain effective working relationships with CROs, investigators, hospitals, laboratories and other external partners.
• Evaluate vendor performance and ensure compliance with agreed deliverables.
• Participate in vendor selection and qualification activities.
• Resolve operational and commercial issues through effective negotiation and stakeholder management.

Candidates with a career background involving one or more of the following are preferred:

• Clinical Research Associate (CRA)
• Clinical Research Coordinator (CRC)
• Clinical Trial Manager (CTM)
• Clinical Project Manager
• Clinical Research Manager
• Clinical Operations