Clinical Feasibility Lead

8 years

0 Lacs

Posted:1 week ago| Platform: Linkedin logo

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On-site

Job Type

Full Time

Job Description

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Role Overview:

The Feasibility Lead is responsible for managing and delivering comprehensive feasibility assessments for early-phase clinical trials. This role ensures the scientific, operational, and regulatory viability of proposed sites and countries, and supports proposal development through collaboration with internal stakeholders and external clients.


Key Objectives:

  • Lead feasibility planning and execution to support project bids and early engagement efforts.
  • Drive data-driven site and country selection strategies.
  • Serve as the subject matter expert in feasibility best practices and ensure alignment with global regulatory requirements.


Key Responsibilities:

1. Subject Matter Leadership

  • Provide strategic input on protocol design, country, and site selection.
  • Stay updated on global feasibility trends and regulatory guidelines.
  • Guide teams on interpreting feasibility data in line with business objectives.
  • Contribute to process improvement initiatives and knowledge sharing.

2. Project Execution

  • Lead feasibility components across multiple projects ensuring timely, high-quality deliverables.
  • Anticipate challenges and proactively design mitigation strategies.
  • Optimize internal resources and manage feasibility timelines effectively.

3. Reporting & Documentation

  • Develop and present regular updates, dashboards, and ad hoc reports for internal and external stakeholders.
  • Maintain clear records for audits and client reviews.

4. Quality Assurance

  • Ensure compliance with ICH-GCP, company SOPs, and regulatory frameworks.
  • Participate in internal audits and implement corrective actions where required.
  • Promote a culture of quality and continuous improvement.

5. Process Optimization

  • Contribute to the creation and refinement of SOPs related to feasibility.
  • Identify inefficiencies and recommend enhancements to improve scalability and consistency.

6. Team Development & Collaboration

  • Support onboarding and mentoring of new or junior team members.
  • Foster a collaborative work environment and facilitate cross-functional knowledge sharing.
  • Participate in resource planning discussions to support strategic growth.

Key Performance Indicators (KPIs):

  • Timeliness and accuracy of feasibility reports
  • Success rate of project bids supported
  • Client satisfaction in feasibility discussions
  • Compliance with SOPs and regulatory requirements
  • Contribution to team development and knowledge sharing
  • Clarity and transparency in feasibility reporting

Internal & External Collaboration:

  • Internal:

    Department and functional heads (e.g., BD, Clinical Operations, Regulatory)
  • External:

    Sponsors, Clients, Global Site Networks


Candidate Requirements:

Education:

  • Bachelor's degree in

    Pharmacy

    (mandatory); higher degrees in life sciences or clinical research are a plus.

Experience:

  • Minimum

    8 years of relevant experience

    in clinical trial feasibility or clinical development.
  • Experience in feasibility planning for early-phase clinical trials (Phase I/II).
  • Exposure to global clinical trials is preferred.

Technical Competencies:

  • Strong understanding of clinical development and regulatory landscapes
  • Proficiency in feasibility platforms, site databases, and data analytics tools
  • CRM tools and Microsoft Office Suite (Excel, PowerPoint, Outlook)

Behavioural Competencies:

  • Strong decision-making and problem-solving abilities
  • Effective communication and interpersonal skills
  • Coaching and mentoring mindset
  • Ability to collaborate across functions and lead without direct authority

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