Sr CTA / Contracts Specialist fixed-term contract Sponsor-dedicated in Europe
7 days left
- Experience Level
- Experienced (non-manager)
Sr Clinical Operations Specialist/Sr CTA with contracts activities
Denmark or anywhere in EU
Syneos Health is looking for split Sr CTA role with contracts activities to one of our big Pharma Client located in Denmark. Selected candidate could be home-based anywhere in Europe. We expect 6 months fixed-term contract with possibility to prelong or move to permanent position within Sponsor structure.
- to be part of clinical trial teams and responsible for specialty deliverables and support to the team members
- to coordinate handling of Trial Master File (TMF) documents together with the Clinical Project Manager, CRAs and CROs
- to ensure quality and completeness of the electronic TMF
- to drive the Investigator Trial File creation process and ensure timely delivery at trial sites
- to ensure essential documents meet technical requirements for electronic submission
- to ensure the administrative completeness of the clinical study protocol and report
- to coordinate process of review and negotiation of site agreements, CDAs, ICIs and NCIs and contract amendments if needed
- to ensure that the clinical trials are insured correctly
- Experience from a similar role in the pharmaceutical industry; either from a sponsor or a CRO
- Solid skills in driving processes, handling and organising tasks. Thrive in an international environment where excellent stakeholder management is a key requirement
- Knowledge of ICH/GCP
- Fluency in written and verbal English
- Ability to prioritise and handle many varied tasks each day
- Ability to work consistently, keep focus on details while maintaining speed and quality
- Knowledge, flair and interest for working in Document Management systems as well as Trial Management systems, such as CTMS
- Knowledge of eTMF systems, such as Veeva Vault
- knowledge about contracts process will be only asset
Equal Opportunities Plan. Its objective is to achieve the principle of equality of opportunity in Syneos Health’s employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions.
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.