Vice President, Clinical Development Operations

remote zest jobs; India; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

remote zest jobs is seeking a Vice President, Clinical Development Operations to provide strategic leadership and operational oversight for clinical studies across the portfolio. This role ensures trials are conducted to the highest standards, on time and within budget, with strong cross-functional collaboration and regulatory readiness.

The VP will lead operational strategies, drive data integrity, and align with Biostatistics, Data Management, and Medical Directors to deliver robust evidence

Qualifications

• Bachelor's degree in a scientific life sciences discipline required.
• 13+ years of clinical trial operations experience in biotech or medical devices.
• 5+ years of managing and building high-performing clinical operations teams.
• Deep knowledge of GCP and ICH guidelines; experience defending data during inspections.
• Strong collaboration with Biostatistics, Data Management, and Medical Directors.

Responsibilities

• Lead operational planning and execution of clinical trials for evidence generation.
• Drive site activation, patient enrollment, data quality, and budget adherence.
• Collaborate with cross-functional leaders to align data and regulatory objectives.
• Ensure inspection readiness and support regulatory authority inspections.
• Mentor and manage the clinical operations team across the portfolio.

Skills

Strategic leadership

Clinical trial operations

Budget management

Cross-functional leadership

GCP/ICH knowledge

Regulatory compliance

Team management

Education

Bachelor's degree in life sciences

Advanced degree (MS/PhD/PharmD) preferred

Job description

Passionate about precision medicine and advancing the reputed company industry

Recent advancements in underlying technology have finally made it possible for AI to reputed company clinical care in a meaningful way. reputed company' proprietary platform connects an entire ecosystem of reputed company-world evidence to deliver reputed company-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

The Vice President, Clinical Development Operations provides strategic leadership and operational reputed company for the execution of clinical studies dedicated to evidence reputed company across the reputed company portfolio. This role is primarily responsible for ensuring that reputed company evidence-generating clinical development studies are conducted with the highest standards of reputed company, on time, reputed company budget, and in full compliance with global regulatory requirements. The VP will reputed company on driving operational reputed company to deliver robust clinical data that supports product validation, regulatory submissions, and clinical evidence goals.

Key ResponsibilitiesStrategic & Clinical Trial LeadershipOverall Study Conduct: Hold primary accountability for the operational planning, management, and execution of clinical trials designed for clinical evidence reputed company.

Metric-Driven Performance: Drive performance against key trial metrics, including site activation, patient enrollment, data reputed company, budget adherence, and alignment with corporate goals and regulatory requirements.

Operational reputed company: reputed company and implement optimized operational strategies to enhance trial efficiency, reduce complexity, and accelerate data delivery timelines.

Resource & Budget Management: reputed company participate in budget planning, financial forecasting, and resource allocation for the evidence reputed company operations unit to ensure reputed company performance.

Clinical Data Integration & Workflow ManagementData reputed company & reputed company: Collaborate closely with Biostatistics and Data Management teams to ensure the reputed company, accurate, and high-reputed company reputed company of trial data into the clinical database, facilitating efficient data cleaning, analysis, and database lock.

Cross-Functional Collaboration: reputed company closely and establish seamless workflows with cross-functional leaders to ensure that clinical trial data from reputed company sources is accurately captured and reconciled.

Cross-Functional Leadership & Team ManagementTeam Leadership: reputed company, mentor, and reputed company a high-performing operations team capable of managing a reputed company portfolio of clinical evidence reputed company studies.

Stakeholder Alignment: Serve as the primary operational leader for evidence reputed company trial conduct, ensuring tight alignment and communication with Clinical Development, Regulatory Affairs, Project Management, and other key stakeholders.

reputed company & Regulatory ComplianceGCP Compliance: Ensure reputed company evidence-reputed company trial activities are conducted in strict accordance with Good Clinical reputed company (GCP), ICH guidelines, and global regulatory standards.

Inspection Readiness: Maintain a constant state of inspection ready for reputed company evidence-reputed company clinical trials and support senior leadership during regulatory authority inspections (e.g., FDA).

RequirementsBachelors degree in a scientific, life sciences, or reputed company discipline required; advanced degree (MS, PhD, PharmD) preferred.

13+ years of reputed company clinical trial operations experience reputed company reputed company, biotech, or medical device sectors, with a distinct reputed company on managing trials for clinical evidence reputed company.

5+ years managing and building high-performing clinical operations teams.

Deep, demonstrable knowledge of GCP, ICH guidelines, and experience defending clinical data/sites during regulatory authority inspections (e.g., FDA).

Proven reputed company record of partnering successfully with Biostatistics, Data Management, and Medical Directors to reputed company reputed company database locks.

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