Clinical Operations Specialist

About the role

The Clinical Operations Specialist provides essential operational support to the Clinical Development and Operations team, coordinating departmental and study support within agreed timeframe, budgets, and compliance. This role supports HCP transparency reporting, contract and invoice management, and departmental activities.

Responsibilities

• Supports invoice and purchase order administration by raising RDCPs/RDAs, processing invoices, tracking payments, and maintaining overall financial trackers
• Supports contract management by initiating contracts in Legisway for legal/procurement review, raising new purchase orders, tracking and filing associated documentation, conducting document reviews and monitoring contract expiry dates
• Supports new HCP and consultant onboarding with the coordination of compliance checks, onboarding, contracting, tracking payments and filing documents
• Solves invoice discrepancies and maintains documentation
• Supports budgets and forecast reviews
• Supports healthcare provider (HCP) transparency reporting requirements adhering to applicable global transparency obligations in line with Legal and Ethics and Compliance departments
• Manages documentation and audit trails related to transparency reporting by collecting, tracking and reconciling HCP payment data from clinical trial activities and Advisory Boards, maintaining a global HCP reporting tracker
• Co-ordinates and submits quarterly and annual HCP compliance reports to Ethics & Compliance department
• Co-ordinates with Procurement, Legal, and Ethics and Compliance departments, and where necessary, coordinates with CRO/HCPs, to ensure accurate and timely payments and reporting
• Supports internal audits, inspections, or compliance reviews related to transparency data
• Coordinates global on/off boarding processes for permanent and contract personnel, liaising with HR and IT
• Coordinates tracking, reconciliation and scheduling of all training requirements
• Coordinates IT and system access and issues support
• Supports communications and survey management
• Supports and coordinates internal and external meetings
• Coordinates SOP training and compliance review ensuring the latest versions of SOPs are available to the department and tracking future updates
• QMS administrator for Trackwise and MasterControl activities
• Supports audit and inspection readiness activities
• Supports clinical teams with reconciliation, tracking, data entry and QC review
• Supports study archive records including mapping and file retrieval/testing processes
• Supports TMF and documentation maintenance, ensuring completeness and compliance with Good Clinical Practice (GCP), SOPs, and regulatory requirements. Supports administrative TMF maintenance activities
• Supports the instruction and training of clinical team and/or delegated third parties in the use of the eTMF
• Supports the preparation of clinical trial documents in conjunction with clinical research personnel and/or external vendors
• Supports the coordination of regular interim internal Trial Master File QC checks

Requirements

• Bachelor's degree preferred or equivalent work experience can be considered
• Detail oriented
• Strong communication skills
• Strong organization and time management skills, along with any project or deadline tracking
• Prior TMF experience
• Ability to learn new tools/systems quickly and become a SME
• Prior experience running the types of reports mentioned in the job description
• Able to handle a high volume of work
• Curiosity
• Able to identify where improvements or enhancements are needed and implement upon approval

Qualifications

• Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.
• Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
• This policy applies to all employment terms, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
• Kedrion Biopharma Inc. offers numerous benefits to our qualifying employees, including:
• Medical, vision and dental insurance
• Life and AD&D insurance
• Paid holidays
• PTO accrual
• and much more!

Benefits

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!