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Clinical Trials Manager

Clinical Trials Manager

Continental HospitalsHyderabad, Republic Of India, IN
2 days ago
Job description

Job Summary :

Continental Hospitals is seeking a dedicated and experienced Clinical Research Coordinator with a minimum of 3 years of experience in clinical trials. The ideal candidate will be responsible for the coordination, management, and execution of clinical research studies in compliance with applicable regulations, protocols, and institutional policies.

Key Responsibilities :

  • Study Coordination : Oversee day-to-day operations of clinical research projects, ensuring smooth and efficient execution from initiation through completion.
  • Subject Recruitment & Enrollment : Manage the recruitment and enrollment process for study participants, ensuring they meet all inclusion / exclusion criteria.
  • Data Collection & Management : Ensure accurate and timely collection of study data, and maintain complete, organized, and compliant study documentation.
  • Compliance & Protocol Adherence : Ensure all clinical trials are conducted according to Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements. Monitor adherence to the study protocol and make necessary adjustments as needed.
  • Patient Care Coordination : Communicate with study participants regarding their visits, procedures, and any other relevant study information. Ensure proper follow-up, including adverse event reporting and participant safety.
  • Collaborative Coordination : Liaise with internal and external stakeholders, including research teams, physicians, and regulatory bodies, to facilitate the successful completion of clinical trials.
  • Regulatory Documentation : Prepare and maintain all regulatory documentation, including informed consent forms, case report forms, ethics committee submissions, and sponsor-related documentation.
  • Quality Assurance : Conduct routine site visits and audits, ensuring compliance with all study-related activities and providing corrective actions where necessary.
  • Training & Mentorship : Train and mentor junior research staff and new hires in clinical trial processes, protocols, and GCP standards.

Qualifications :

  • Education : Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
  • Experience : Minimum of 3 years of experience as a Clinical Research Coordinator or in a similar clinical research role, in Multispecialty Hospitals
  • Certifications : Certification in Clinical Research (e.G., ACRP or SOCRA) is preferred.
  • Skills :
  • Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
  • Ability to manage multiple clinical trials simultaneously.
  • Excellent organizational and time management skills.
  • Strong interpersonal and communication skills, both written and verbal.
  • Detail-oriented with a focus on accuracy and compliance.
  • Ability to work collaboratively in a team environment and independently as needed.
  • Preferred Qualifications :

  • Experience with electronic data capture (EDC) systems and clinical trial management software.
  • Experience with hospital-based clinical research trials, patient recruitment, and compliance monitoring.
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    Manager • Hyderabad, Republic Of India, IN

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