Clinical Business Operations Associate-Contracts & Budgets

Clinical Business Operations Associate-Contracts & Budgets
Our client, a global pharma company are currently recruiting for a Clinical Business Operations Associate-Contracts and Budgets to join their Clinical Development team on a permanent basis.

Responsibilities

• Establish, maintain and archival of compound-related files and trial-related files as required
• Create and maintain clinical plan and compound information
• Given a final protocol, lead the authoring of Clinical Trial 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)
• 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 and assisting 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 processes
• Create and maintain collaboration sites at process, compound or trial levels for the organization
• Collaborate in the development and maintenance of business processes
• Represents the Clinical Business Operations in the assessment and contracting of potential vendors as appropriate
• 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
• 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
• Work to assess vendor performance, share TPO performance metrics with 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 pharmaceutical industry experience)
• Knowledge and understanding of technical details of clinical study protocols, especially as regards subject inclusion/exclusion criteria, schedules of events and procedures
• Experience in clinical development, familiarity with medical terminology, and good clinical practice requirements
• Exploratory and biopharmaceutics clinical development study processes, clinical site operations
• 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