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SSU Project Delivery - Europe

Geplaatst 23 mrt. 2024
Werkervaring
0 tot 1 jaar
Full-time / part-time
Full-time
Functie
Soort opleiding
Taalvereiste
Engels (Vloeiend)

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19005799SSU Project Delivery - all levels considered: Lead, Manager, Senior Manager and Associate DirectorHome based anywhere in Europe

At Syneos Health we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory and Patient Recruitment.

As a member of our Study Start Up team you will traverse all therapeutic areas and phases, providing your expertise at this vital period of time in the study. This expertise at this critical time has resulted in the average study start up time four weeks faster than industry standard.

We are currently are looking to strengthen our SSU Project Delivery department within Europe; all levels considered: Lead, Manager, Senior Manager and Associate Director to be based in Europe.

A brief summary of duties you will be involved in:- Acting as a key point of contact with the sponsor and internal team regarding all Regulatory activities for the assigned study

  • Overseeing all associates assigned to work on the regulatory, ethics and essential document portion of the study

  • Assuming responsibility on deliverables at the project level

  • The planning, coordination and oversight of all processes involved in gaining approvals required in each country for a clinical trial to commence. This will include competent authority approvals, ethics committee approvals, import license approvals, radiation approval, tissue/biological sample export and any other local approvals required in a given country.

  • Dealing with multiple countries and studies at any given time.

To succeed in this role you will need the following skills/experience:

  • Degree educated or equivalent in a science or healthcare field

  • Direct experience making CA submissions across multiple countries- Oversight experience of Site Contracts and Submissions processes

  • Excellent understanding and experience in Regulatory laws, processes, mindset, document requirements, drug labeling requirements, and drug release requirements in multiple European, APAC and Americas countries

What happens next:

If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.

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.

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Primary Location

Europe - GBR-Home-Based

Other Locations

Europe - POL-Home-Based, Europe - ITA-Home-Based, Europe - SVK-Home-Based, Europe - NOR-Home-Based, Europe - ROU-Home-Based, Europe - FIN-Home-Based, Europe - DEU-Home-Based, Europe - HUN-Home-Based, Europe - BGR-Home-Based, Europe - RUS-Home-Based, Europe - SWE-Home-Based, Europe - IRL-Home-Based, Europe - FRA-Home-Based, Europe - SRB-Home-Based, Europe - NLD-Home-Based, Europe - ZAF-Home-Based, Europe - ESP-Home-Based (Madrid), Europe - UKR-Home-Based, Europe - BEL-Home-Based, Europe - ISR-Home-Based, Europe - CZE-Home-Based, Europe - ESP-Home-Based (Barcelona), Europe - DNK-Denmark-Home-Based

Job

Site Start Up

Schedule

Full-time

Travel

Yes, 25 % of the Time

Employee Status

Regular

Expected Salary Range Depending on experience

INC Research/inVentiv Health has become Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization. We are purpose-built for biopharmaceutical acceleration, creating better, smarter, faster ways to help clients navigate an increasingly complex marketplace.

Farmaceutisch
London
10.000 medewerkers