JOB SUMMARY
The Manager - Clinical Trials Office coordinates and implements the Clinical Trial Office at Sidra. S/he will supervise and manage clinical trials for investigators, drug companies, government agencies and academic institutions. The incumbent oversees trials, ensuring they are executed correctly and follow the correct protocol.
KEY ROLE ACCOUNTABILITIES
- Establishes implements and maintains policies and procedures aiming to ensure adherence to trial protocols and administrative requirements.
- Ensures that all clinical trials suffice the regulatory requirements.
- Assures compliance to SOPs and local regulations, and CFR, ICH and GCP guidelines.
- Updates staff on institutional policies/procedures changes.
- Provides Clinical Research Associates with project-specific training and having regular meetings with them.
- Acts as the point of contact for internal stakeholders (Legal, Pharmacy, investigators, IRB, etc.) and all external agencies.
- Collaborates with other functions and workgroups to ensure that all regulatory requirements are satisfied
- Manages the quality assurance and regulatory requirements for the clinical trials
- Manages the GCP (Good Clinical Practice), JCI, ISO and other accreditations, as applicable.
- Establishes implements and maintains specific Quality Management Plan (QMP) for Advanced Therapy Medicinal Product CRP.
- Gathers and examines trial documents.
- Monitors the progress of study subjects and the overall trial.
- Co-ordinates the preparation and publication of data, reports and information, ensuring that they meet legislative, contractual and ethical requirements.
- Understands the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and coordinating any necessary audit processes.
- Liaisons with the Internal Research Committee, HRP Program, IRB and MOPH with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements.
- Provides regular and ad hoc information, both written and verbal, to all the trial participants and sponsors, to include reports, updates, guidance, preformed commitments and possibly a newsletter.
- Works with the Chief Investigator to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time.
- Adheres to Sidra’s standards as they appear in the Code of Conduct and Conflict of Interest policies
- Adheres to and promotes Sidra’s Values
In view of the evolving needs and opportunities within Sidra, this position may be required to perform other duties as assigned and reporting relationships may vary.
QUALIFICATIONS, EXPERIENCE AND SKILLS – SELECTION CRITERIA
ESSENTIAL PREFERRED Education Bachelors in Science, Healthcare, Research and Pharmacy. Bachelor in Management field PhD.
Experience
5+ years of experience with progressive responsibilities in relevant field inclusive of:
- Experience in pharmaceutical company
- Management experience and in coordination of clinical trials
Job Specific Skills and Abilities
Ability to create Procedures/Work. Instructions/Document Template.
Excellent communication and presentation skills.
Proficient understanding of marketing and statistics.
Knowledge of the main Quality Systems (Joint Commission, ISO, etc.).
Demonstrated ability to conduct audits and report non-conformity and violation.
Ability to organize and motivate others.
Showing flair, enthusiasm, innovation and leadership when faced with challenges and will provide strategic, tactical and operational management skills in the planning and execution of the trials.
Ability to work independently and prioritize duties.
Understanding of Electronic Data Capture (EDC).
Proficiency with Microsoft Office suite
Fluency in written and spoken English
Sidra Medicine a healthy population is essential to a strong, prosperous society, and throughout 2020, Sidra continued to provide uninterrupted comprehensive specialist healthcare services for children and young people; and exceptional maternity, gynecology, and reproductive medical services for women, previously unavailable in Qatar and the region.” – H.H Sheikha Moza bint Nasser, Chairperson of Qatar Foundation
Sidra Medicine represents the vision of Her Highness Sheikha Moza bint Nasser who serves as its Chairperson. This high-tech facility is home to world-class patient care, scientific expertise, and educational resources.
