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Manager Clinical Site Contracts
Manager Clinical Site ContractsBlueRock Therapeutics • Cambridge, MA, United States
Manager Clinical Site Contracts

Manager Clinical Site Contracts

BlueRock Therapeutics • Cambridge, MA, United States
2 days ago
Job type
  • Full-time
Job description

Who is BlueRock?

BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson's disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives.

The Manager, Clinical Site Contracts will play a critical role in managing the full lifecycle of contracts supporting research, clinical development, and business. This role requires a proactive, detail-oriented, professional capable of negotiating, drafting, and managing complex agreements in a fast-paced, collaborative environment. The ideal candidate possesses strong knowledge of biotech and pharmaceutical contract types included, Clinical Trial Agreements (CTAs), Confidentiality Disclosure Agreements (CDAs), Master Clinical Trial Agreements (MCTAs), and Consulting Agreements (CA).

Key Responsibilities :

  • Prepare, review, and negotiate a variety of contracts including CTAs, MCTAs, CDAs, and consulting agreements in compliance with company policies and industry standards.
  • Oversee the end-to-end regional / global site contracting process-from intake and drafting through execution and renewal-ensuring timely delivery and alignment with project and business objectives li, with a focus on implementing effective and sustainable processes, templates, and tools.
  • Accountable as the primary BlueRock communication conduit for all site contracting matters. Identify contractual risks and provide guidance to stakeholders to mitigate exposure while supporting company goals.
  • Work closely with Legal, Clinical Operations, Procurement, Finance, and R & D to ensure contracts reflect appropriate business and risk positions
  • Create and maintain investigational grants financial benchmarks for assigned clinical trials. Drive alignment for financial negotiation parameters and manage financial escalations when applicable to ensure compliance adherence.
  • Work closely with Finance and Operations stakeholders to establish study / project forecasts and manage relevant financial tracking and accruals / review invoices. Ensure adherence to time-based site payment disbursement goals.
  • Support Purchase Order generation and management.
  • Support / manage process improvement efforts, including but not limited to ensure adherence to BRT standards, and all applicable regulations and guidelines.
  • Review / develop business terms, BRT Working Practices, Standard Operating Procedures (SOPs), templates, training, platforms and systems to drive improvements that are advantageous to BRT.
  • Represent values-based leadership consistent with BRT Core Values : courage, urgency, integrity and community.

Minimum Requirements :

  • Bachelor's degree and 4+ years of site contracting experience within the pharmaceutical industry, or equivalent combination of advanced degree and experience. JD or paralegal Certification a plus.
  • Experience managing vendors and CROs preferred, especially in the context of clinical operations and study start-up workstreams.
  • Familiarity with contract management systems (e.g. Ironclad, DocuSign CLM, Agiloft, or similar).
  • Demonstrated ability to multi-task and prioritize while working on multiple competing priorities.
  • Strong attention to detail and organizational skills.
  • Excellent verbal and written communication skills.
  • Strong understanding of legal and regulatory principles in clinical research
  • Ability to work independently.
  • Advanced Proficiency in MS Office (Word, Excel, PowerPoint) and ability to quickly learn new technologies and processes.
  • Must be customer focused and able to manage challenging priorities and remain flexible and adaptable in stressful situations.
  • Willing to travel up to 15% of the time.
  • #LI-AL1

    BlueRock Therapeutics Company Culture Highlights

    Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023

    Winner of Comparably's Award for Best Company for Diversity 2022

    Winner of Comparably's Award for Best Company for Women 2022

    Winner of Comparably's Award for Best CEO 2022

    BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.

    Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.

    Check us out on Comparably : https : / / www.comparably.com / companies / bluerock-therapeutics

    Follow us on Linkedin : https : / / www.linkedin.com / company / bluerocktx /

    Equal Opportunity Workplace :

    At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

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    Site Manager • Cambridge, MA, United States

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