Jobgether
Site Contract Specialist II
legalfull-timeIndia
SALARY
Not listed
WORK TYPE
remote
JOB TYPE
full-time
INDUSTRY
general
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About the role
Accountabilities:
- Manage site contract activities at the project level, coordinating protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documentation.
- Support multi-country clinical trial projects by preparing and negotiating site contracts, budgets, amendments, and related documentation under appropriate supervision.
- Support the development and agreement of country-level contract and budget templates and prepare site-specific agreements from approved templates.
- Coordinate contract and budget submissions, negotiations, issue resolution, quality control, execution, document archival, and metadata capture.
- Work closely with contract managers and project team members to actively track and resolve outstanding contractual issues.
- Monitor contracting milestones against forecasted country and site timelines and maintain accurate, real-time project tracking.
- Collaborate with legal, finance, clinical operations, vendors, sponsors, investigators, and other internal and external stakeholders to communicate and resolve contractual or budgetary matters.
- Maintain contract templates, site-specific files, databases, training materials, and project documentation.
- Provide functional guidance, mentorship, and training to less experienced team members while supporting departmental SOPs and quality standards.
- Support business development activities and represent site contracting and study start-up functions in internal and customer-facing meetings.
- Monitor basic financial aspects of assigned projects, identify discrepancies, and escalate issues appropriately.
- Identify opportunities to streamline contracting and internal processes and introduce practical solutions that improve efficiency and quality.
- Ensure compliance with applicable SOPs, work instructions, training requirements, and timesheet processes.
- Bachelor’s degree in Business Administration, Public Administration, Public Health, or a related discipline, or an equivalent combination of education and experience; an advanced degree is preferred.
- Significant experience in contract management, ideally within a contract research organization, pharmaceutical company, or related clinical research environment.
- Strong knowledge of clinical development processes, contracting principles, and relevant legal and regulatory considerations.
- Solid understanding of clinical trials across Phases I–IV, ICH GCP, clinical protocols, and study specifications.
- Strong knowledge of clinical trial site start-up and contracting processes.
- Demonstrated project management experience in a fast-paced, complex environment, with the ability to manage multiple projects and competing priorities.
- Strong negotiation, problem-solving, vendor management, and stakeholder-management capabilities.
- Excellent written and verbal communication, presentation, documentation, and interpersonal skills.
- Strong proficiency in Microsoft Office Suite and the ability to work effectively with contract and project documentation systems.
- Highly organized and detail-oriented, with a strong commitment to quality and compliance.
- Customer-focused, adaptable, and able to remain effective when managing challenging priorities or stressful situations.
- Ability to work collaboratively with geographically distributed teams and build effective relationships with internal and external stakeholders.
- Demonstrated ability to mentor, motivate, and provide constructive feedback to junior colleagues.
- Ability to contribute to training and quality assurance initiatives and support the continuous improvement of SOPs and work instructions.
- Fully remote work arrangement in India.
- Opportunity to work on global clinical development programs within a collaborative, highly specialized environment.
- Career development and progression opportunities supported by dedicated learning and development resources.
- Technical and therapeutic-area training to strengthen professional expertise.
- Supportive and engaged management and opportunities for peer recognition.
- Comprehensive total rewards and employee support programs.
- Opportunities to collaborate with international teams and gain exposure to diverse clinical, therapeutic, and customer environments.
- Access to emerging technologies, scientific resources, data, and knowledge-sharing opportunities.
- A strong focus on inclusion, belonging, and bringing diverse perspectives into problem-solving.
- Opportunities for long-term career growth across different functions and areas of expertise.
- The chance to contribute to clinical research programs that support the development of therapies designed to improve patients’ lives worldwide.
Requirements:
Benefits:
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