Clinical Project Lead

3 weeks ago

Abu Dhabi, United Arab Emirates Group 42 Full time

Overview:
Insights Research Organization & Solutions (IROS) is the first UAE-based Contract Research Organization (CRO) specializing in healthcare research. From clinical trials across all therapeutic areas to integration of real-world data, we provide the highest international ethical and scientific standards in clinical trial management, as well as key insights that lead to innovative, life-changing treatments.

**Responsibilities**:

- Serves as liaison between study Sponsor, investigational sites, and the contract research organization.
- Contributes during the feasibility and start-up phase.
- Controls submission/approval process to EC/ RA in close collaboration with the clinical research associates and regulatory affairs team.
- Ensures timely report and review of monitoring visit reports (if required) and ensures adherence to study timelines for report submission and finalization.
- Performs co-site visits (qualification, initiation, monitoring and termination) with the CRA, as applicable.
- Assists in compliance of study milestones: start, patient enrolment, overall study and active trial, and timelines as per the contract obligations.
- Updates all implemented study progress tools and trackers monthly and posts them on BOX or transmits them to appropriate destinations.
- Attends regular meetings and calls with CPM to provide updates and discuss issues for which action is required.
- Works closely with the team to ensure studies are completed on time, within the budget, as per the
scope agreed upon with the client, according to the study protocol, and with the quality standards set forth by the local ethics and regulatory requirements, company and client standards and procedures, and as per ICH- GCP.
- Collaborates with internal/external auditors, co-monitors, or regulatory inspectors in review of files
and patient data.
- Collaboration with stakeholders covering different services/tasks within the project and for the resolution of any project-related issues.
- Collaborates and handles all third parties involved in the study; this includes complete re-assessment activities.
- Assists in the preparation of and participate during the Investigator Meetings.
- Assists in contracting process, when required.
- Assists in all logistic processes related to the study.
- Contributes to the study team trainings, meetings, and customization of study-specific forms.
- Provides any requested internal progress reports and completion of the relevant files.
- Contributes to the process of creation and approval of all essential documents developed or tailored inhouse, such as, but not limited to, study-specific templates, patient material, and translated documents.
- Proactively identifies and prevents issues related to the clinical study, including study processes, monitoring, compliance, or site issues.
- Follows and manages the payment of investigator’s fees in collaboration with the CRA.
- Supports Business Development activities, such as meetings and budget development, as applicable.
- Supervises and assesses the performance of team members and provides feedback to respective line managers/ HR for appraisal.
- Executes any activities in compliance with applicable SOPs, instructions, principles, and regulatory guidelines.
- Performs quality checks on study-specific folders and file completions.
- Performs CRA activities in assigned clinical trials as per business needs.
- Serve as Project Manager in small trials, as per business need.
- Other duties as assigned.

Qualifications:

- Life Science Bachelor's Degree or higher required.
Working Experience
- Five or more years of professional experience in the clinical research field in the pharmaceutical industry with at least 1 year of clinical project management experience.
- Five or more years of experience in the field of clinical research; managing at least 4 Interventional CTs.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).
- Previous experience working at a sponsor or CRO company preferred.
- Experience in early phase (Phase I-II) and late phase (Phase III-IV) trials preferred.
- Advanced knowledge of ICH-GCP guidelines, FDA regulations, and all applicable clinical research requirements, national regulations regarding Clinical Trial Application (CTA) and logistic procedures.
- Proficiency in English language: writing, communication, and reading.
- Leadership ability and good sense of teamwork and collaboration.
- Excellent analytical, organizational, negotiation, and decision-making skills.
- Ability to communicate information and ideas clearly so others will understand.
- Ability to listen and understand information and ideas presented both verbally and through written word.
- A valid driving license and willingness to travel within the country and abroad (in the case of a flexible working schedule).
- Good time-management and multitasking skills to coordinate several issues and

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