Site Contract Specialist II (Germany)

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

The Site Contract Specialist II (SCS II) coordinates and performs site contract and budget negotiations at country level, working with the Global Site Contract Manager (GSCM) as well as Global Start-Up Manager or Local Start-Up Lead (LSUL) as applicable. This position supports the site contract and budget negotiation process from template review, preparation of site-level contracts through execution, provides expertise on country requirements and specificities in terms of contract and budget negotiation process. The Site Contract Specialist II is a member of the Study Start-up & Site Intelligence Unit.

Note - This position will be remote/hybrid in Germany

The Site Contract Specialist II will be responsible for the following tasks:

• Assist in review of country-level contract template in the process of templates’ development and approval with Sponsor at the start of the clinical study;
• Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study according to the approved negotiation parameters;
• Support communication with sites and internal personnel regarding the status of contracts and contract related documents
• Identify and assesses legal, financial, and operational risks and escalate to appropriate Global Site Contract Manager (GSCM);
• Provide recommendations and alternative resolutions throughout negotiations using established escalation channels;
• Assist in arranging translation of the final country CTA template and/or negotiated contracts, where applicable
• Provide the final/draft CTA and site budget for submission, where required
• Obtain site signature as well as Sponsor/Allucent signature, as applicable
• Track relevant information and data in CTMS and/or other tracking tools, ensure planned dates are up to date and reliable for study team’s planning of site activation
• Keep up to date with applicable local regulations impacting clinical trial contracts.

Requirements

• Law degree or Paralegal certification preferred or equivalent combination of education, training, and experience
• Minimum 2 years’ experience in contract negotiations in clinical research or drug development area
• A basic understanding of the drug development process.
• Fundamental knowledge of GxP, privacy legislation (GDPR and/or HIPPA), and applicable local regulatory requirements preferred

• Strong written and verbal communication skills including good command of English and German languages
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Strong organization and time management skills
• Administrative excellence, with attention to detail and accuracy
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required

Benefits

• Comprehensive benefits package
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for fully remote working or Hybrid Working Model

• Leadership and mentoring opportunities
• Internal growth opportunities and career progression
• More task variety
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms

To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes