Pharmaceutical Development Company is a leading clinical research organization, providing a Full-Service End-to-End Solution for Phase I to IV clinical trials and NIS /RWE studies in the Middle East and Africa region. Our clients include pharmaceutical, biotechnology, medical device industries, other CROs, and academic organizations. Our team is experienced in managing clinical projects from beginning to completion, PDC has been recognized among the leaders as Clinical Research Organization in the region.
Due to our successful development, we are looking for highly motivated and responsible candidates for the position of:
Name of position: Clinical Project Manager- Location: Egypt
Essential Functions and Other Job Information
- Being and serve as the first point of contact to client.
- Coordination and control over the feasibility, start-up, clinical and site-management activities related to a specific clinical trial within the Division.
- Strict control over the compliance of study milestones: start, patients’ enrolment (overall study) and timelines as per the contract obligations.
- Control over budget, issue, task, and time management of the project/s under their supervision.
- Oversights of submission/ approval process to EC/ RA.
- Communication with sponsors, partner CROs, physicians, third parties and regulatory authorities.
- Manages the process of creation, approval of all essential documents developed or tailored in-house as ICF, patient material and translated documents.
- Responsible for distribution within the team of final approved version of all essential documents (Protocol, IB, CRF, ICF, etc.).
- Initiate qualification and approval, ongoing management, oversight and dealing with all third parties involved in the study; complete re-assessment activities.
- Develops and communicates all study specific plans as PMP, monitoring plan, TMF maintenance plan, communication plan, quality plan, project risk matrix (if applicable) as well as any other study-specific instructions and guidelines.
- Ensures on time study team trainings, meetings, and customization of study-specific forms and plans.
- Control over all logistic procedures related to the study.
- Identify changes, work with team members to quantify financial/ time impact and communicate those changes to appropriate personnel.
- Ensures the contracting process, when required.
- Timely coverage of all assigned trainings.
- Adheres to the rules and regulations of ICH-GCP and other regulatory and ethical guidelines and data protection regulations.
- Coordinates activities between different stakeholders and determine interim study time points.
- Providing any requested internal progress reports and completion of the relevant files.
- Preparation and conducting of Investigator Meetings in close collaboration with the client.
- Collaboration with internal/ external auditors, co-monitors, or regulatory inspectors in review of files and patient data.
- Executes any activities in compliance with applicable SOPs, instructions, and principles.
- Development and update of company SOPs and policies in close collaboration with Management.
- Support Business Development activities in terms of meetings and budget development as applicable.
- Supervises and assesses the performance of team members and provides feedback to respective line manager/ HR for appraisal.
- Perform CPL activities as per assigned clinical trials in all cases as deemed necessary by superior management levels, while avoiding risk of conflict of interest.
Education and Experience
• University degree with life science background or equivalent and relevant formal academic/ vocational
qualification.
• At least 6 years of experience in the field of clinical research; Managing at least 5 Interventional CT.
Knowledge, Skills, and Abilities
• Advanced knowledge of GCP guideline and all applicable clinical research requirements
• Proficiency in English language
• Leadership and good sense of teamwork
• Excellent analytical, organizational, negotiation and decision-making skills
• Ability to communicate information and ideas so others will understand; with the ability to listen to
and understand information and ideas presented through spoken words and sentences.
• Good time management and multitasking skills to coordinate several issues simultaneously.
• Solid interpersonal skills
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Appropriate MS Office Skills
• May interact with others, relating and gathering sensitive information. Interaction includes diverse
groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions based on task prioritization.
• Ability to perform under stress.
• Regular and consistent attendance
Working Conditions and Environment
• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Often travels/ drives to site locations. Frequent travel both domestic and international.
The Company Offer:
- Job-specific training
- Work for successful international company, excellent career development opportunity in a perspective professional field
- Very competitive remuneration package
- Additional benefits related to work performance.
Website
https://pdc-cro.com
The Assigned Country: Egypt
Only short-listed candidates will be contacted for interviews.
Note: By submitting your application, you agree that your personal data will be processed by PDC in accordance with the applicable Data Protection Law and in strictly keeping your confidentiality.
