Company: Docs Global (Continental Europe)
Reference: Ref AS-019814
Closing Date: 08 Dec 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS has partnered with a highly prestigious organisation with one of the most robust pipeline within the industry. We have a great job opportunity for a Start-up Specialists with experience in submissions that are ready to further develop their career and enjoy working for a global organisation in their offices in Warsaw.
Roles & Responsibilities of the position
As a Study Start Up Associate (SSUA) you will be responsible for obtaining clinical trial authorisations, ethical approvals, execution of contracts (including budgets), and ensure that the sites are ready for enrolment.
o Prepare and manage regulatory submissions in countries of responsibilities via European regulatory processes, where applicable, to support clinical research
o Drive collection of required regulatory documents for investigative sites and network with external parties as needed.
o Provide historical site activation data to Clinical Operations teams to enhance site selection discussions ensuring the appropriate sites are participating in the study
o Prepare the initial country/site study-level ICFs, as well as revisions as a result of protocol amendments, risk profile updates, etc.
o Maintain the relevant sections of study Trial Master Files (TMF), any internal reporting systems, and ensure they are inspection ready at all times
o Prepare submission files
o Support review and approve Regulatory Template and Multi-phrase translation packets for label creation, where applicable
o Prepare documentation for site close out and ensure the files are complete and ready for archiving.
o Ensure compliance to the country regulatory requirements within internal systems and maintain it up to date
o Develop/Maintain country and site-specific clinical research templates between the sponsor and external parties in cooperation with legal and compliance functions
o Partner with regional and global functions on development of country budgets
o Negotiate contracts with Institutions and investigators partnering with regional and global functions
o Facilitate contract amendments as and when required.
• Bachelor’s degree or equivalent, in a science or health related field
• At least 2 years Clinical Research experience
• Strong knowledge of regulations, legislation and guidelines applicable for the conduct of clinical studies
• Previous experience in regulatory submissions
• Strong interpersonal skills, including capability to engage in professional relationship building an networking
• Willingness to negotiate site contracts/budgets
Competitive salary, medical insurance, annual holiday and other benefits.
Please contact Dariusz Sternlicht, Recruitment Consultant at DOCS on +48 606 130 397 or email your up-to-date CV to: email@example.com
DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical trial industry.
Contract Negotiation, Regulatory, Start-Up, Budget Negotiation, Regulatory Affairs, RA, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Contract, Warsaw, Poland
2 Globeside, Globeside Business Park
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