Manager, Site Contracts Management

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $122k - $163k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Provide consistent site contract global strategy, oversight, and support at the study level for all operating models on assigned studies. • Serve as an escalation point for language issues from CROs and liaise with R&D Legal to resolve complex negotiations. • Contribute to department and cross-functional process development and improvements. • Develop and maintain oversight of CROs to ensure compliant and timely execution of site contracts and payments. • Provide strategic input on country-level contracts strategy as a regional SME. • Support in-house site contract development and negotiation as necessary. • Monitor trends and contribute to the refinement of existing guidance, tools, and templates. • Facilitate communication between study sites and internal teams to ensure alignment and compliance. • Ensure adherence to GCP, relevant ICH standards, and FDA/EMA guidelines. • Conduct presentations and provide training on site contracts best practices.

🎯 Requirements

• Bachelor’s degree • 6+ years’ experience in the biotechnology/pharmaceutical industry within the site contracting outsourcing space. • Fully proficient in project management and site contract and budget negotiation and execution across Phase I-IV clinical trials. • Thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines. • Excellent negotiation skills, conflict resolution, decision-making skills, and presentation skills. • Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe. • Bachelor’s Degree required; MBA/MPA/MPH/JD (or equivalent) preferred but not required.

🏖️ Benefits

• Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays + 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation