Clinical Project Manager

3 weeks ago

Abu Dhabi, United Arab Emirates Group 42 Full time

Overview:
Insights Research Organization & Solutions [IROS], a subsidiary of G42 Healthcare, was established in 2021 in Abu Dhabi. IROS is the first UAE-based Contract Research Organization (CRO) specializing in healthcare research, including clinical trials across all therapeutic areas, in addition to the generation and integration of real-world data. The first of its kind research organization in the entire Middle East, it provides international, ethical, and scientific quality standards in clinical trial reporting, as well as key solutions and insights that ensure access to more innovative, life-changing treatments.

**Responsibilities**:
As a part of your role, you will conduct and manage internal QA audits in order to assure that studies managed by IROS are on the highest standard and in compliance with applicable laws and regulations.

Key responsibilities

Reporting the Director of Clinical Operations, you will lead and participate in process & quality improvement processes and initiatives.
- Proactively plans and monitors clinical trials.
- Serves as the first point of contact for client.
- Coordinates and maintains control over the feasibility, start-up, clinical and site-management activities related to specific clinical trials; this includes review and approval of site visit reports, as well as tracking, follow up, and resolution of issues in a timely manner.
- Maintains strict control over the compliance of and adherence to study milestones: start, patient enrolment, overall study and active trial, and timelines as per the contract obligations.
- Controls budget, issues, tasks, and time management of assigned project/s.
- Communicates with Sponsors, partnering CROs, physicians, or regulatory authorities
- Manages the process of creation and approval of all essential documents developed or tailored in-house, such as, but not limited to, ICF, Patients Material, and translated documents.
- Responsible for distribution and comprehension within the team of final approved versions of all essential documents (e.g. Protocol, IB, CRF, ICF).
- Develops and distributes to the team any study-specific manuals, instructions, and guidelines.
- Initiate selection and approval, ongoing management, oversight for all third parties involved in the study; this includes complete re-assessment activities.
- Control over all logistic procedures related to assigned studies.
- Identify changes, work with team members to evaluate and quantify financial/time impact, and communicate those changes to appropriate personnel.
- Contributes to the contracting process, when required.
- Oversees submission and approval process to EC/RA.
- Ensures on-time study team trainings, meetings, and customization of study-specific forms.
- Coordinates activities between different stakeholders and determines interim study timepoints.
- Provides any requested internal progress reports and coordinates completion of the relevant files.
- Prepares and conducts Investigator Meetings in close collaboration with the client.
- Collaborates with internal/external auditors, co-monitors, and/or regulatory inspectors in review of files and patient data.
- Executes activities in compliance with applicable SOPs, instructions, principles, and regulatory guidelines.
- Develops study specific plans, such as PMP, monitoring plans, TMF maintenance plans, communication plans, quality plans, and project risk matrix (if applicable).
- Develops and updates company SOPs and policies in close collaboration with Management.
- 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.
- Performs CPL activities, as per assigned clinical trials, in all cases as deemed necessary by superior Management levels, while avoiding risk of conflict of interest (as per CPL Job Description).
- Other duties as assigned.

Skills and attributes for success
- 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.
- Good time-management and multitasking skills to coordinate several issues and tasks simultaneously.
- Solid interpersonal skills, including ability to interact clearly with others, relate and gather sensitive information, and interact with diverse groups of individuals.
- A valid driving license and willingness to travel within the country and abroad (in the case of a fl

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