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).