AYMEN MOMIN
Set up/ Project Management
Navi Mumbai
Summary
Professional and hardworking with thorough knowledge of Clinical research, working in the clinical research industry for six years, dealt with several protocols with efficiency and solution driven attitude. Expertise in clinical study protocols, set up and project management for various pharmaceutical companies and CRO's, while adhering to study specific timelines and requirements. Driven and motivated for newer opportunities while maintaining quality and proficiency. Innovative and goal-oriented professional committed to quality. Dedicated team player skilled at mediation and conflict resolution. Drives company growth through creative, cost effective and high performance goals.
Overview
7
7
years of professional experience
3
3
years of post-secondary education
2
2
Languages
Work History
Associate Lab Project Set up Manager
IQVIA
6 2023 - Current
- Developing the design requirements for study start up activities in central laboratory for various protocols.
- Preparing the design documents from Client's requirements for full protocols.
- Understanding and delivering Client's standards in accordance with Clinical Protocol.
- Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management.
- Communicating and coordinating set-up activities with clients and internal customers to ensure a smooth study start up phase.
- Proactive in managing changes in study related project scope by identifying any potential risks.
- Worked on a Yellow belt project to increase efficiency and reduce time consumed for the process by 70%.
- Worked on an Audit, represented study start up activities, completed with no concerns or comments from the Auditors.
- Mentored junior team members for career advancement, fostering a pipeline of future leaders within the organization.
Senior Lab Project Set-up Co-ordinator
IQVIA
06.2021 - 05.2023
- Assist in the development of database design requirements, including configuration. (e.g. project specific kit contents, laboratory events, requisitions, medical reports and programming)
- Conduct configuration and programming reviews.
- Contribute to project planning, such as creating accurate project timelines, complying with regulatory steps, and identifying potential project related issues.
- Lead set-up activities and communications with client and or sponsor counterparts, assist project processes and activities.
- Use knowledge of protocol specific and routine tasks to ensure outputs are delivered in line with organizational standards and client expectations.
- Managed project timelines for successful completion, ensuring milestones were met and deadlines were adhered to.
Lab Project Set-up Co-ordinator
IQVIA
07.2018 - 05.2021
- Configure project databases.
- Perform a database configuration review and assist with validation of database specifications.
- Perform study complexity and verification checks and database change requests.
- Participate in local and global improvement projects as defined by the relevant process improvement.
- Keep Project Managers and other relevant staff informed of any issues that may affect the smooth transition of the study set up activities.
Laboratory Assistant
IQVIA
11.2017 - 07.2018
- Dengue vaccine production - Performed plaque counting and data processing on Elispot software.
- Work in collaboration with the team to minimize errors and increase productivity.
Education
Post Graduate Diploma - Clinical Research, Data Management And Medical Writing
University of Mumbai
Mumbai 04.2018 - 04.2019
Master of Science - Microbiology
University of Mumbai
Mumbai 01.2015 - 04.2017
Skills
- Knowledge of all LIMS systems for setting up databases for Clinical Research
- Set-up of various protocols in Newlims, Qlims and LTMS system
- Communication and interpersonal skills with a strong hold on negotiations
- Performance Management
- Skilled to work with varied sponsors and departments
- Mentoring and Leadership
- Practical approach to the problem
- Effective in achieving Milestones
- Project Management
- Professional attitude and work ethics
Accomplishments
- Three databases configured with a 100% start up survey scores by the sponsor.
- Six Sigma Yellow Belt certified. (Reduced overprocessing in the database setup activity to enhance overall reduction in the time consumed, by 70%)
- Recognized for doing the highest number of verification checks in Set up for post launch studies for two consecutive years. (2018-20)
- Pursuing Six Sigma Green Belt.
Personal Information
Date of Birth: 05/18/94
Timeline
Senior Lab Project Set-up Co-ordinator
IQVIA
06.2021 - 05.2023
Lab Project Set-up Co-ordinator
IQVIA
07.2018 - 05.2021
Post Graduate Diploma - Clinical Research, Data Management And Medical Writing
University of Mumbai
04.2018 - 04.2019
Laboratory Assistant
IQVIA
11.2017 - 07.2018
Master of Science - Microbiology
University of Mumbai
01.2015 - 04.2017
Associate Lab Project Set up Manager
IQVIA
6 2023 - Current
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