Riem Tawfik
Mississauga
Summary
Dynamic Senior Project Specialist with extensive experience excelling in clinical trial management support and documentation.
Proven track record in optimizing processes and fostering collaboration, while demonstrating excellent communication and professional integrity.
Adept at managing eTMF and training initiatives, ensuring compliance and timely project milestones throughout the study lifecycle.
Experienced with managing large-scale projects and driving project success through effective planning and execution. Utilizes strong organizational and leadership skills to ensure project milestones are met. Track record of leveraging communication and problem-solving abilities to achieve project goals.
Overview
15
15
years of professional experience
Work History
Senior Project Specialist II
Allucent
04.2023 - Current
- Global study set-up: clinical systems initiation requests, study project management tracker, study eTMF and others.
- Study meetings, KOM, F2F meetings and investigator meetings coordination and attendance; responsibility of recording meeting minutes, Q&A and Action Items as needed; finalizing and distributing to study team.
- Assisting Project Manager, and function leads with study set-up, maintenance and close out administrative activities.
- Manage study specific training process, study specific training matrix updates, training distribution and training verification forms tracking and archiving throughout the life of the study.
- Assist in updating study timelines, milestones and other study tracking tools in CTMS, Smartsheet and internal sharepoint system.
- eTMF set-up, maintenance and reconciliation throughout the life of the study until exportation to sponsor.
- Assisting sponsor and third parties vendors with administrative activities as required.
- As DSMB admin carrying on with DSMB administrative responsibilities as assisting with DSMB charter drafting, finalization & distribution, DSMB meetings coordinating, meeting minutes preparation and distribution, DSMB recommendation form preparation and distribution as required.
- · Other arisen responsibilities to support study team, sponsor, third parties to help stirring the progression of the clinical trial meeting milestones and reach its projected targets from start to finish.
Senior Project Specialist I
Allucent
06.2018 - 04.2023
- Assisting with study set-up, maintenance and close out.
- CTMS / Sharepoint: Improved project efficiency by implementing streamlined processes and optimizing resource allocation.
- eTMF: championed continuous improvement initiatives within the organization by sharing best practices learned from past projects experiences.
- Established solid working relationships with external partners to facilitate collaboration on joint ventures or outsourced projects tasks.
Senior Clinical Trial Associate
Pharm-Olam International
03.2016 - 05.2018
- Streamlined clinical trial start set-up, maintenance and close out administrative activities. providing efficient support to study team, sponsor and third parties.
- Ensured compliance with regulatory guidelines, maintaining accurate and up-to-date records throughout all phases of the trial.
- Responsibilities: Meetings coordination and minutes preparation, eTMF, Investigator site files preparation, systems maintenance, study specific training management, other activities to support study functional leads and third party vendors.
- Supported the successful completion of all study milestones by proactively identifying potential challenges and implementing well-coordinated action plans to address them.
Clinical Trial Associate III
Pharm-Olam International
01.2014 - 03.2016
- Providing ongoing efficient administrative support to study team from start-up to close out, meeting timelines and increasing productivity.
- Developed strong relationships with internal study team, sponsor and site personnel, fostering a collaborative environment conducive to successful trial execution.
Clinical Trial Associate II
Pharm-Olam International
05.2010 - 03.2014
- Clinical trial administrative support from start to finish, providing efficient assistance to study Project Manager, internal study team, sponsor and sites.
Education
Bachelor of Arts - Fine Arts
Faculty of Fine Arts
Alexandria, Egypt07-1992
High School Diploma -
Ste Jeanne Antide Institute
Alexandria, Egypt04-1987
Skills
- Excellent Communication Skills
- Scope management
- Creative solutions
- Customer Oriented
- Documentation and reporting
- Mentoring and coaching
- Professional Integrity
Languages
French
Full Professional
English
Full Professional
Arabic
Native or Bilingual
Timeline
Senior Project Specialist II
Allucent
04.2023 - Current
Senior Project Specialist I
Allucent
06.2018 - 04.2023
Senior Clinical Trial Associate
Pharm-Olam International
03.2016 - 05.2018
Clinical Trial Associate III
Pharm-Olam International
01.2014 - 03.2016
Clinical Trial Associate II
Pharm-Olam International
05.2010 - 03.2014
Bachelor of Arts - Fine Arts
Faculty of Fine Arts
High School Diploma -
Ste Jeanne Antide Institute
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