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Experienced Clinical Research and Drug Safety QA Consultant, Scientific Copy Editor
Melis Mengütay
,
London, United Kingdom
Experience
Other titles
Skills
I'm offering
Having a scientific background (molecular biology & genetics MSc) with 3 years of clinical research experience in Pharma industry, I have been copy editing journal articles in the field of medicine to ensure that the final text is error-free and meets journal language specifications. I also remotely support ad-hoc good clinical practice (GCP) and drug safety (GVP) audits, follow up CAPA of pharma companies around the world since 2017.
Other services I provide include: Medical translation (Turkish-English), content writing, document QC.
Other services I provide include: Medical translation (Turkish-English), content writing, document QC.
Markets
United States
(Remote
only)
Canada
(Remote
only)
United Kingdom
France
(Remote
only)
Germany
(Remote
only)
Lithuania
(Remote
only)
Denmark
(Remote
only)
Norway
(Remote
only)
Sweden
(Remote
only)
Finland
(Remote
only)
Links for more
Once you have created a company account and a job, you can access the profiles links.
Industries
Language
English
Fluently
Ready for
Larger project
Ongoing relation / part-time
Full time contractor
Available
My experience
2019 - ?
freelance
Copy Editor
Copy edit accepted journal articles in the field of medicine to ensure that the final text is error-free and meets journal language specifications.
Style various elements of a journal article according to given guidelines.
Style various elements of a journal article according to given guidelines.
Copy editing, Communication, Scientific Writing, Medical and Health Science writing and editing, Life Science, Pharmaceutical, Biotechnology
2017 - ?
freelance
Clinical Research and Pharmacovigilance QA Consultant
Xera Consultancy Ltd.
UK
❖ Working with a global Pharmacovigilance and clinical oversight and training consulting firm in the UK to plan and support of GxP audits for the clients (2017 - Present).
❖Working with global scientific communications company to copy edit accepted journal articles in the field of medicine to ensure that the final text is error-free and meets journal language specifications.
❖ Working with a global Pharmacovigilance and clinical oversight and training consulting firm in the UK to plan and support of GxP audits for the clients (2017 - Present).
❖Working with global scientific communications company to copy edit accepted journal articles in the field of medicine to ensure that the final text is error-free and meets journal language specifications.
Research, Training, Consulting, Support, Pharmacovigilance, Founder, Copy editing, Communication, Project Management
2015 - 2017
job
Clinical Research Associate
Monitor CRO.
TR
Job Summary:
Responsible for two Phase III studies across 8 sites as CTA and in-house CRA, a Phase I study and an observational study across 4 sites as CRA.
* Collected and/or followed up essential documents and contracts, prepared TMF and ISF for study sites;
* Quality review of the study site files for organization and completeness periodically (for study start-up and throughout the studies);
* Initiated, monitored and closed out clinical study sites;
* Was the central point of communication between Sponsor and Investigators for all clinical trial related activities;
* Assured trials are conducted on time while being fully ICH-GCP, FDA and Sponsor SOP compliant;
* Ensured reliable documentation and archiving of study documents at the investigational site and for the eTMF;
* Followed-up on monitoring and oversight visit findings and action plans (CAPAs);
* Established regular lines of communication with sites to manage ongoing project expectations and reports critical contacts in Clinical Trial Management System (CTMS);
* Followed up with site staff in timely Case Report Form completion and submission, and data query resolution;
* Ensured timely access to systems and trainings for site staff and correct data entry in CTMS and related systems;
* Followed up with site staff in timely protocol and related study training to assigned site staff;
* Collaborated with different study team members for project execution support
* Facilitated site supply management oversight.
Clinical Studies:
❖ Pfizer Inc. / Julius Clinical CRO, NE - CTA + In-House CRA (outsourced for 22 months)
Phase 3, Multicentre, International, Randomized, Double-blind, Placebo-controlled, Parallel Group Evaluation of reducing the occurrence of major Cardiovascular Events in high risk Subjects (SPIRE-1, SPIRE-2)
❖ Bio Products Laboratory (BPL), UK - CRA (outsourced for 16 months)
A Multicentre, Retrospective Data Collection Study on the Use of Company's High Purity Factor X in the Treatment of Patients with Hereditary Factor X Deficiency (Ten05)
❖ TRPharm, TR - Unblinded CRA (outsourced for 4 months)
A Randomized, Double-blind, Placebo-controlled, Single-centre, Phase 1, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
Job Summary:
Responsible for two Phase III studies across 8 sites as CTA and in-house CRA, a Phase I study and an observational study across 4 sites as CRA.
* Collected and/or followed up essential documents and contracts, prepared TMF and ISF for study sites;
* Quality review of the study site files for organization and completeness periodically (for study start-up and throughout the studies);
* Initiated, monitored and closed out clinical study sites;
* Was the central point of communication between Sponsor and Investigators for all clinical trial related activities;
* Assured trials are conducted on time while being fully ICH-GCP, FDA and Sponsor SOP compliant;
* Ensured reliable documentation and archiving of study documents at the investigational site and for the eTMF;
* Followed-up on monitoring and oversight visit findings and action plans (CAPAs);
* Established regular lines of communication with sites to manage ongoing project expectations and reports critical contacts in Clinical Trial Management System (CTMS);
* Followed up with site staff in timely Case Report Form completion and submission, and data query resolution;
* Ensured timely access to systems and trainings for site staff and correct data entry in CTMS and related systems;
* Followed up with site staff in timely protocol and related study training to assigned site staff;
* Collaborated with different study team members for project execution support
* Facilitated site supply management oversight.
Clinical Studies:
❖ Pfizer Inc. / Julius Clinical CRO, NE - CTA + In-House CRA (outsourced for 22 months)
Phase 3, Multicentre, International, Randomized, Double-blind, Placebo-controlled, Parallel Group Evaluation of reducing the occurrence of major Cardiovascular Events in high risk Subjects (SPIRE-1, SPIRE-2)
❖ Bio Products Laboratory (BPL), UK - CRA (outsourced for 16 months)
A Multicentre, Retrospective Data Collection Study on the Use of Company's High Purity Factor X in the Treatment of Patients with Hereditary Factor X Deficiency (Ten05)
❖ TRPharm, TR - Unblinded CRA (outsourced for 4 months)
A Randomized, Double-blind, Placebo-controlled, Single-centre, Phase 1, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
Research, Training, Management, Support, Cro, Monitoring, International, Data collection, Safety, Contracts, UP
2014 - 2014
job
Clinical Trial Administrator
EBM Clinical Research Services.
TR
Job Summary:
• Ensured that TMFs are organised, maintained and complete,
• Assisted the project team in order to realize an optimal logistic and administrative management of the clinical studies.
Job Summary:
• Ensured that TMFs are organised, maintained and complete,
• Assisted the project team in order to realize an optimal logistic and administrative management of the clinical studies.
Management, Administrator
My education
2013
Institute of Applied Plant Nutrition
N/a, Research Assistant
N/a, Research Assistant
2012
-
2014
Sabanci University
MSc, Biological Sciences and Bioengineering
MSc, Biological Sciences and Bioengineering
2010
Institute of Human Genetics
N/a, Research Assistant
N/a, Research Assistant
2006
-
2011
Sabanci University
BSc, Biological Engineering
BSc, Biological Engineering
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