Site Contract & Activation Specialist
Company: Docs Global (Continental Europe)
Location: Warsaw, Poland
Closing Date: 16 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Competitive salary, medical insurance, annual holiday and other benefits.
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/Regulatory Specialists with experience in site contract negotiations who are ready to further develop their career and enjoy working for a global organisation in their offices in Warsaw, Poland.
As a Site Contracts & Activation Specialist 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.
Contracts and budget management
- Develop/Maintain country and site-specific clinical research templates between the sponsor and external parties in cooperation with legal and compliance functions
- Partner with regional and global functions on development of country budgets
- Negotiate contracts with Institutions and investigators partnering with regional and global functions
- Facilitate contract amendments as and when required.
- Develop and maintain country legal guidance documents / library and budget negotiation history
- Serve as a primary contact for sites and investigators in matters relating to contracts
- Keep internal functions informed about status and progress in contract negotiations
- Ensure that essential clinical study documentation related to contracts/budgets/ within country of responsibility is managed in compliance with Good Clinical Practices (GCP) and appropriate Quality Standards
- Prepare and manage regulatory submissions in countries of responsibilities via European regulatory processes, where applicable, to support clinical research
- Drive collection of required regulatory documents for investigative sites and network with external parties as needed.
- Provide historical site activation data to Clinical Operations teams to enhance site selection discussions ensuring the appropriate sites are participating in the study
- Coordinate translation process for all required trial documents and oversee the quality of final documents.
- Prepare the initial country/site study-level ICFs, as well as revisions as a result of protocol amendments, risk profile updates, etc.
- Contribute to the country specific ICF template review.
- Drive timelines for both ERB/CA submissions and approvals, of country-level regulatory package
- Develop and maintain relationships with ERB/CA, where applicable.
- Identify potential issues and anticipate current trends related to regulatory/ethical issues and create plan to mitigate them.
Clinical Operations responsibilities
- Maintain the relevant sections of study Trial Master Files (TMF), any internal reporting systems, and ensure they are inspection ready at all times
- Prepare submission files
- Support review and approve Regulatory Template and Multi-phrase translation packets for label creation, where applicable
- Prepare documentation for site close out and ensure the files are complete and ready for archiving.
- Ensure access to study systems is provided during site activation.
- Update and track country study-level tasks for site activation
- Ensure compliance to the country regulatory requirements within internal systems and maintain it up to date
- Provide support before, during and after audits/inspections
What is 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 contracts and budget negotiations
- Strong interpersonal skills, including capability to engage in professional relationship building an networking
- ·Be able to verify translations (make good sense in local languages, is clear and readable) and to be able to adapt language readable format for a patient, where applicable
What is offered
We offer: 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: firstname.lastname@example.org
Key words: 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