Mahak Beg
TMF Document Specialist
Raipur
Summary
Experienced Research Associate and Currently TMF specialist I, with a demonstrated history of 2.7 years of working in the outsourcing/offshoring industry. Skilled in Clinical research and trials, Clinical Data Management, Research and Development, Organization Skills, Analytical skills and Project Management.
Trained and certified in rDNA technology techniques, food technology techniques and Clinical Research, CDM & basic PV.
Strong research professional with a Master of Science - focused in Biotechnology and Microbiology from Guru Ghasidas University.
Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
3
3
years of professional experience
5
5
years of post-secondary education
4
4
Certificates
2
2
Languages
Work History
TMF Document Specialist I
Syneos Health
Home-based-Pune
04.2021 - Current
- Evaluate and process the expected vs actual study documents in a Trial Master File (TMF) based on a pre-determined set of expected documents in accordance with the Standard Operating Procedures (SOPs), GCP, ICH, FDA guidelines and study specific TMF plans.
- Support the set-up, maintenance and closure of TMF repositories.
- Identify, review and resolve document filing issues, reindex documents into the correct location and add placeholders where documents are found to be missing.
- Identify quality issues and escalate according to processes set out.
- Maintain compliance with departmental quality, performance and utilization targets, complete administrative tasks as requested and be compliant with company time tracking and training.
- Participates in preparation/reconciliation of TMF documentation related to audits like MHRA, inspections and verification.
- Data validation i.e. Cross checking against source documentations to ensure eTMF completeness and inspection readiness.
- Participates in study specific training as required.
Research Associate - Clinical
EP group
Raipur
10.2019 - 01.2021
- Conducted literature reviews.
- Designed and implemented research & clinical trial protocols.
- TMF document evaluation and QC.
- Collected, analyzed & arrayed primary and secondary data.
- Maintenance of Clinical trial databases.
- Scientific writing (Protocols, Reports, Manuscript and articles)
- Medico-marketing writing.
- Maintained Sponsor and Vendor relationship & communication.
- Supported overall clinical trial activities ranging from inception of studies to supporting ongoing study activities.
Education
Master of Science - Biotechnology
Guru Ghasidas University
Bilaspur, Chhattisgarh 07.2017 - 07.2019
Bachelor of Science - Biotechnology
Guru Ghasidas University
Bilaspur, Chhattisgarh 06.2014 - 07.2017
Skills
Clinical Data Management
Certification
Certification - Clinical Research, Clinical Data management & PV from Omasy Research Institute, Chennai. - India
Additional Information
Father’s Name – Mr. Mustakeem Mirza Beg
Mother’s Name – Lt. Mahenaz Mirza Beg
Date of birth – 26.08.1996
Marital status – Single
Religion – Islam
Nationality – Indian
Timeline
TMF Document Specialist I
Syneos Health
04.2021 - Current
Certification - Clinical Research, Clinical Data management & PV from Omasy Research Institute, Chennai. - India
02-2021
Internship - rDNA technology & Mol. Boi. from LTU and WLC - IIT, kharagpur, India
01-2020
Research Associate - Clinical
EP group
10.2019 - 01.2021
Certification - Basic rDNA & Mol.Bio technique from Cytogene Research & Development Ins., Lucknow, U.P. - India
01-2019
Certification - Food Technology -Food Analysis & Quality Control from Cytogene Research & Development Ins., Lucknow, U.P. - India
07-2018
Master of Science - Biotechnology
Guru Ghasidas University
07.2017 - 07.2019
Bachelor of Science - Biotechnology
Guru Ghasidas University
06.2014 - 07.2017
Declaration
Availability- Need to serve 2 months’ notice period
Declaration- I hereby declare that all the details furnished above are true to the best of my knowledge.
MAHAK BEG
Date- 11.07.2022
Place – Raipur, Chhattisgarh.
Declaration
Availability- Need to serve 2 months’ notice period
Declaration- I hereby declare that all the details furnished above are true to the best of my knowledge.
MAHAK BEG
Date- 11.07.2022
Place – Raipur, Chhattisgarh.
Similar Profiles
MARIA E. FERNANDEZMARIA E. FERNANDEZ
Team Lead Full-Service REMS at Syneos HealthTeam Lead Full-Service REMS at Syneos Health
Jessica Alejandra Mateos RodríguezJessica Alejandra Mateos Rodríguez
Senior Clinical Research Associate at Syneos HealthSenior Clinical Research Associate at Syneos Health
Zach SoperZach Soper
Pharmaceutical Sales Specialist at Syneos HealthPharmaceutical Sales Specialist at Syneos Health
Disha Nitin JoshiDisha Nitin Joshi
Analytical Scientist II at Syneos HealthAnalytical Scientist II at Syneos Health
Kandala Sai Sri PawanKandala Sai Sri Pawan
PMO Analyst at CapgeminiPMO Analyst at Capgemini