Regional Clinical Trial Manager, Global Top 10 Pharma
Consultant Archita Tekriwal (R1659919)
Job Ref 1828250/001
Date posted 15 July 2022singapore technical-healthcare/clinical-research 2022-07-15 2022-08-14 pharmaceuticals Singapore SG Robert Walters https://www.robertwalters.com.sg https://www.robertwalters.com.sg/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
A brand new role of Regional Clinical Trial Manager has just been created at a global top 10 Pharma Company
About the role
As Regional Clinical Trial Manager you will be accountable for the operational management of the all the regional component of a clinical trial for the globally leading Pharma company.
- Lead Clinical Trial Preparation, Conduct and Closeout: Selected sites conduct and deliver the trial according to the clinical trial protocol within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations.
- Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts and necessary approvals.
- All Regulatory Requirements are satisfied prior to trial/site initiation.
- Where necessary, set up and manage external suppliers that meet requirements of local/regional trial operations.
- Set up, manage and review regional / local trial budget to ensure appropriate level of financial oversight. Timely budget updates based on trial changes.
- Ensure appropriate trial-specific training of regional / local internal and external partners in line with Trial Training Plan.
- In collaboration with Site Monitoring Lead and CRAs, ensure a) provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and company team to GCP, local regulations, company SOPs, and adherence to trial protocol; b) adequate trial supply distribution to sites; c) continuous and timely data entry and cleaning, and on time Data Base Lock.
- Trial contact for CRAs, investigators and site staff.
- In collaboration with Trial Record Specialist and with supports from CRAs as appropriate, ensures collection of required documents, with timely, complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices.
To be successful in this role you will need to be passionate about clinical trial management, be extremely detail oriented and able to manage projects well as you role is to assure achievement of trial recruitment commitment, timelines, budget and internal/external quality standards.
- At least 10 years of experience in Clinical Development/Clinical Affairs/Scientific Affairs of which at least 2years in the project management of clinical trials
- Define and implement strategies for Clinical Development acceleration for the countries in the region
- Highly developed project management and team leadership capability, ability to work independently and as part of a team.
- Excellent communication and interpersonal skills. - Structured mindset, good scientific, medical and analytical thinking.
- Highly committed to timelines AND delivery of maximum quality data.
- Full and permanent awareness of ethical responsibility inherent to research involving human subjects.
- Good knowledge of the Clinical Development process including the regulatory requirements
- Good English language skills (spoken and in writing).
- Prompt responsiveness, outstanding ability to cope with multiple requests and to work under time pressure.
- Proficiency in all common office software and smooth self-training of new software programmes (user).
- Ability and willingness to travel domestic and overseas and to use electronic means of communication.
About the company
Taking up this role you will be joining one of the world's largest pharmaceutical companies which is present globally across 146 countries and with more than 45,000 employees. The company's key areas of interest are: respiratory diseases, metabolism, immunology, oncology and diseases of the central nervous system.
If you have the relevant experience as required above and want to take on a role that could change the trajectory of your career, do not miss this exciting Regional Clinical Trial Manager position.
Apply now to find out more.
Do note that we will only be in touch if your application is shortlisted.
Robert Walters (Singapore) Pte Ltd
ROC No.: 199706961E | EA Licence No.: 03C5451
EA Registration No.: R1659919 Archita Tekriwal
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