Theradex Oncology has designed and performed more than 350 early-phase oncology trials to date. As a full service CRO, Theradex Oncology knows how to assist its clients in developing successful strategies and execute studies in cancer treatment. Our mission is to ensure that new opportunities in drug development have the very best chance to be of benefit to mankind, with a vision to make cancer a livable disease. With over 40 years of experience focused entirely on oncology, we are passionate specialists. We understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Our head office is based in Princeton, NJ, USA, while our European operations are managed from our London office.

We are looking for native Polish speaking, Clinical Site Contract Specialist (Contractor) based in Poland on a 0.5 FTE for a 6 months contract.

Interaction

• Interacts with European Head of Legal Affairs on a routine basis in accordance with the task to be executed.
• Serves as the primary point of contact for Investigator Sites in Poland.

Key Responsibilities

The primary responsibilities of this position include, but are not limited to, the following:

• Directly negotiating and finalizing Clinical Trial Agreements and Budgets for Industry-Sponsored Clinical Trials in Clinical Studies from phase I till Phase IV in Poland according to instructions, timelines and milestones agreed with European Head of Legal Affairs and Study Team.
• Acting as Subject Matter Expert in the negotiation with the Polish sites for all clinical trial studies in the Company.
• Liaises with European Head of Legal Affairs to finalize timelines, strategy and plans for contracts in Poland for each all clinical study in EU.
• Liaises with Clinical Sites on a regular basis to obtain feedback on contract and budget negotiation according to European Head of Legal Affairs instructions.
• Reporting and escalating issues related to negotiation of the clinical trial agreements to Contract Manager in fashionable time and according to the plan agreed with Study Team, SOP and instructions given by European Head of Legal Affairs.
• Tracking and monitoring progress and actions related to Contracts and Budgets assigned for each site in each country according to the tools provided for that study, SOP and instructions given by European Head of Legal Affairs and Study Team and keep weekly tracker for each study up to date on a weekly basis.
• Assisting European Head of Legal Affairs with the preparation of the country template and country budget for each study in each country according to European Head of Legal Affairs Instructions.
• Assisting European Head of Legal Affairs with the direct translation of any document from Polish to English and vice versa.
• Directly reviewing and customizing budget, contract, and amendment according to protocol Synopsis, tools and templates provided by European Head of Legal Affairs Poland Assisting the European Head of Legal Affairs with the revision of budget, contract, and amendment according to protocol Synopsis, tools and templates provided by European Head of Legal Affairs Poland.
• Building and keeping good relationships with all sites/sites contact. Attending internal study meetings or Sponsor meeting as requested by European Head of Legal Affairs.
• Working independently with the negotiation of contract and Budget in Poland.

Level of Education

• Life Science or Legal degree and experience in budget and contract negotiation in previous CRO or Pharmaceutical Company

Prior Experience:

• 2-3 years’ experience in Budget and Contract negotiation in Poland gained in CRO or Pharmaceutical Company
• Working in a CRO or pharmaceutical / health related business environment preferred
• Working knowledge of Site Contract and/or paralegal background preferred

Skills and Competencies needed:

• Good interpersonal skills.
• Highly organized and detail orientated.
• Ability to prioritize workload and develop effective processes.
• Proficient working knowledge of MS-Word and Excel
• Good communication skills verbal and written.
• Fluent knowledge of written and verbal English
  
• Fluent native Polish speaker

What we offer:

Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.

This job does not offer company sponsorship