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Sr. Associate/Manager – Contracts & Budgets

Sr. Associate/Manager – Contracts & Budgets

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  • Permanent
  • Anywhere

Bespoke Recruitment

Primary Responsibilities: 


Study Development and Execution Support:

  • Establish, maintain, and archival compound-related files and trial-related files as required per procedures.
  • Create and maintain clinical plans and compound information in IMPACT.
  • Given a final protocol, lead the authoring of CT Registry entries at the beginning of a trial.
  • Obtain or prepare relevant documentation necessary for a clinical trial based on GCP or Local regulations for Site Activation, Maintenance, and Close-out (e.g., New Trial Statements for insurance certificates, copyright permissions, and document translations, Clinical Trial Applications)
  • Assist in the planning, forecasting, and tracking of trial budgets, Pos, and invoices.
  • Support efforts in establishing consulting agreements (vendors and investigators).
  • Understand FRAP and consult with teams regarding FRAP compliance.
  • Ensure Legal, Procurement, and Financial processes are completed for assigned TPOs.
  • Support study teams with sourcing activities by:
  • Gaining agreement on sourcing timelines and expectations with the team.
  • Liaising with Procurement to obtain competitive study bids.
  • Preparing Study Work Orders (SWOs) and contracts with Procurement and Legal.
  • Assists study teams with issue escalation and dispute resolution when needed.
  • Participate in ongoing business and quality reviews with TPOs.
  • Work to resolve quality issues arising from internal and external assessments and audits.
  • Work with the corporate contracts group to help facilitate the FMV process.


Systems and Processes Support:

  • Create and maintain collaboration sites at process, compound, or trial levels for the organization.
  • Proactively establish and ensure accuracy and completeness of information in Veeva Vault Clinical, IMPACT, Planisware, and other critical business systems, producing reports as needed.
  • Collaborate in the development and maintenance of business processes
  • Represents the Clinical Business Operations in the assessment and contracting of potential vendors as appropriate.
  • Includes Anti-corruption due diligence.
  • Help maintain study archetype templates
  • Support knowledge management and archival activities for the organization
  • Provide support for tools to support portfolio delivery.
  • Provide support for Training curricula assignments and system updates.
  • Provide leadership in the Protect company’s Privacy / GDPR (EU) / other compliance initiatives.


Metrics, Reporting, and Systems Maintenance:

  • Identify, evaluate, and interrelate data using means to advise business processes and enable organization decisions, investigate issues, and identify trends and improvement areas.
  • Create and run system reports for metrics as well as proactively address gaps in required fields.
  • Support reviews of GCP issues and compliance reporting.
  • Generate organizational metrics/measures, milestone reports, staff capacity reports, and other reports as needed (e.g. bottleneck reports)
  • Support capacity planning and accurate reporting of project time through coordination of CATS entries.
  • Support the use of systems and databases (for example: Trackwise deviation or change mgmt systems).
  • Work to assess vendor performance, and share TPO performance metrics with the company management.
  • Manage and maintain Org Charts and Job Descriptions

Basic Requirements:

  • Bachelor’s Degree in a scientific or health-related field; or equivalent qualifications/experience (3 years of pharmaceutical industry experience).
  • Strong self-management, analytical and organizational skills.
  • Experience with contract management with vendors and/or clinical sites
  • Demonstrated problem-solving abilities.
  • Ability to prioritize and handle a high volume of activities.
  • Proficiency with business software packages.
  • Strong communication (verbal and written) skills and willingness to collaborate globally.
  • Ability to travel (varies dependent on responsibilities – if responsibilities require travel up to 10% expected).
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