Sr. Associate/Manager – Contracts & Budgets
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
- 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).