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Associate / Sr Associate - Contracts & Budgets

Reference:AOORAXMQ-422655
Location: Cork
Cork City
Qualification:Degree
Experience:1-2 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Business Analyst, Nurse Associate

Organization Overview:

The purpose of the Clinical Business Operations (CBO) Associate role is to serve as technical and process expert in exploratory and biopharmaceutics clinical development and the support of the portfolio, clinical trials, and business processes. Key areas of support include: a) study development and execution systems and processes, b) study related contracting and budgeting and c) metrics and reporting. In addition to knowledge of ICH and quality guidelines needed for successful delivery of the portfolio and clinical trials, the CBO Associate possesses the business acumen, process knowledge, and influence required to substantively participate in process and quality improvement efforts. The Associate will seek knowledge from internal and external sources and use this information to shape continuous improvement opportunities.

Primary Responsibilities: This job description is intended to provide a general overview of the various job requirements. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with supervision regarding actual job responsibilities and any related duties that may be required for the position.
Study Development and Execution Support:

  • Establish, maintenance and archival of compound-related files and trial-related files as required per procedures.
  • Create and maintain clinical plan and compound information in IMPACT.
  • Given a final protocol, lead the authoring of CT Registry entries at 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 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 assignment and system updates.
  • Provide leadership in the 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 use of systems and databases (for example: Trackwise deviation or change mgmt systems).
  • Work to assess vendor performance, share TPO performance metrics with client 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 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).
For further information on the role contact Alan O Riordan on alan.oriordan@lifescience.ie or via phone on 087 365 7522.



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