Contract Lead - Remote

Study Start Up Romania


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Contract Lead to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

What you'll be doing:

  • Is responsible for preparing, negotiating, tracking and finalizing the Confidentiality Agreements (CDA), Clinical Trial Agreements (CTA), Budgets and Letters of Indemnification (LOI) as well as Amendments to these documents, as needed.
  • Negotiates final CDA and CTA templates with clients, and the internal project team.
  • Manages all required contractual agreements with investigator sites.  This includes distribution, negotiation of budget and language, tracking and finalization.
  • Independently communicates with client designee on all contract-related items.
  • Escalates issues appropriately to the Project Manager.
  • Proactively identifies site contract related risks and potential roadblocks.
  • Prepares contract approval timelines with investigators and leads efforts to obtain contract approval to meet study deliverables.
  • Participates in project-related meetings.
  • Maintains communication with client, project team and sites regarding status of all contractual requirements.
  • Assists in development and implementation of new initiatives and negotiation/execution processes.
  • Collaborates with the project team to ensure the client deliverables and expectations are achieved.
  • Provides a handoff to the project team upon execution of a site’s final contractual documents.
  • Liaises with internal customers to review contract or budget areas that impact final execution of site contracts.
  • Maintains tracking regarding site contracts and provides regular updates as agreed by the study team to the project team and client regarding status and efforts to ensure timelines are maintained.
  • Ensures that Premier Research, clinical investigators, institutions and our clients have contractual agreements in place that are clear, fair and legally binding.
  • Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to CDAs, CTAs, investigator grants, and LOIs.
  • Provides training on clinical site contractual requirements and negotiation.
  • Mentors and trains junior level staff.
  • Participates in corporate initiatives and actions that ensure the continued success of the company.
  • Provides performance feedback on project team members for annual appraisals.
  • Other activities as designated.

What you'll need:

  • Undergraduate degree or its international equivalent in business administration, legal studies or life sciences from an accredited institution.

Level I

  • At least 1 year of legal experience with contract language, budget development and negotiations
  • At least 1 year of related industry experience (CRO preferred)
  • Ability to work with internal and external customers/vendors to meet project-specific goals
  • Interacts with site, clients and other functional areas as secondary project contact for contracting issues and questions
  • Manages time and project requirements base on study deliverables

Level II

  • Same accountabilities as Level 1
  • At least 2 years of legal experience with contract language, budget development and negotiations
  • At least 2 years of related industry experience (CRO preferred)
  • Assist with mentoring and training staff
  • Provides input in local SOPs and WGs
  • Support for the creation of internal training materials

Level III

  • Same accountabilities as Levels 1 & 2
  • 3+ years of legal experience with contract language, budget development and negotiations.  Preferably clinical study related.
  • Advanced legal training/course work preferred
  • Serves as Primary Liaison for clinical site contract management for a study or program
  • Knowledge of ICH / GCP regulations
  • Working knowledge of FDA Guidance Documents / EU Directives / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Knowledge of web-based communication tools for conferences and any other IT systems required for the job
  • Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site start-up activities will be carried out.
  • Fluent verbal and written English as well as the local language(s) required for clinical trial submissions
  • Excellent team player, collaborative and able to build an effective team
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities
  • Strong verbal and written communication and negotiation skills
  • Excellent organizational and time-management skills, able to prioritize work to meet deadlines
  • Accountable, dependable and demonstrates strong commitment to the role
  • Is customer service focused in approach to work, both internally and externally
  • Maintains a positive, results-orientated work environment

    #LI-RS1