What are the responsibilities and job description for the Clinical Team Lead position at KlinEra Global Services Inc?
Job Description :
We are seeking a highly skilled and motivated Clinical Team Lead to oversee and manage various clinical trial activities, ensuring compliance with regulatory requirements and timelines. The ideal candidate will have expert theoretical and practical knowledge of ICH-GXPs, international and local regulatory requirements, and possess the ability to train and mentor others in these areas.
Required Education / Experience
A graduate or postgraduate with science, medical, and / or pharmaceutical background
Diploma or degree in Clinical Research.
Minimum of 5 years of experience in clinical trials with at least 3 years in a leadership or supervisory role within a CRO or pharmaceutical company.
Key Responsibilities :
Provide expert knowledge of ICH-GXPs and regulatory requirements applicable to Clinical Operations, ensuring compliance and training team members.
Accurately identify and manage SAEs, ensuring proper documentation and follow-up actions.
Proactively identify and resolve study-related issues, improving timelines and ensuring efficient project delivery.
Assist Senior Clinical Project Manager (Sr.CPM) in projecting timelines, managing study deliverables, and co-monitoring activities.
Contribute to the review and finalization of trip visit reports and follow-up letters within set timelines.
Track and report monitoring visit frequencies as per project monitoring plans.
Conduct and lead visits, including training / mentoring visits, and assist in team development.
Maintain high-quality study-related files, both electronically and in hardcopy, ensuring audit standards are met.
Demonstrate excellent communication skills with internal and external stakeholders, including study teams, site staff, senior management, sponsors, and vendors.
Facilitate team-building, conflict resolution, and negotiations to ensure productivity and adherence to project timelines.
Provide constructive feedback and mentoring to Clinical Research Associates (CRA) and other team members.
Actively engage in client meetings, teleconferences, bid defense meetings, and development of study-related documents.
Manage unit-based contracts and budgets, ensuring profitable staff utilization and recovery.
Participate in investigator site contract negotiations, site payment management, and basic analysis of payment data.
Support the recruitment process for Clinical Operations personnel and provide feedback as requested.
Develop and implement Risk and Contingency Plans to address potential study risks.
Manage medium to large / complex cross-functional projects while ensuring adherence to timelines and budgets.
Lead audits and inspections, ensuring CAPA resolution and compliance.
Oversee and maintain study files to audit standards and ensure quality trip reports and follow-up letters.
Monitor tracking systems for errors, trends, and data analysis, providing feedback for continuous improvement.
Support staff recruitment, retention initiatives, and minimize turnover by promoting a positive team culture.
Align with organizational objectives and adapt to additional responsibilities as required.
Maintain a strong customer focus, ensuring stakeholder satisfaction.
Qualifications :
In-depth knowledge of ICH-GXP guidelines, international and local regulatory requirements.
Proven experience in managing clinical trials and overseeing clinical operations teams.
Strong training and mentoring skills with the ability to manage and coach junior team members.
Excellent communication, problem-solving, and organizational skills.
Ability to work independently with minimal supervision, managing multiple tasks effectively.
Proficiency in tracking systems and data analysis for clinical trials.
Experience with site contract negotiations, budgeting, and payment processes.
Ability to manage risk, perform audits, and ensure CAPA follow-through.
Strong leadership qualities with a focus on team development and productivity.
Why Join Us?
Competitive salary and benefits package.
Opportunities for career growth and professional development.
Collaborative and supportive team environment.
Work with innovative and cutting-edge clinical research projects.
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