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Clinical Contract Manager
1 month ago
Clinical Contract Management Role at Avania
Clinical Contract Management is a new and exciting offering at Avania, responsible for managing clinical trial agreements and other types of agreements with clinical sites, investigators, and other related stakeholders in the startup and execution of a clinical study.
These activities are billable (except for internal structural and line management tasks) and encompass developing processes, toolkits, and contract management tasks for clinical studies, including review, negotiation, progress tracking, finalization, and other related activities as may be requested by the Avania client.
The Clinical Contract Management team undertakes the following varied duties:
- Process Development: Designs and implements global and regional processes and workflows for site contracts and budget negotiation.
- Template Development: Develops CCM templates, negotiates guidelines, procedures, and tools.
- Contract Management: Populates, reviews, and negotiates study and site-specific contracts and budgets.
- Proposal Review: Reviews client proposals/RFPs.
- Support and Collaboration: Supports in preparing materials on CCM service offering strategy and improvements in collaboration with Business Development.
- Contract Management: Handles contract management of site contracting and budgeting processes.
- Collaboration and Communication: Collaborates with BAP and Finance on CCM pricing, units, and necessary processes and tools.
- Relationship Building: Establishes relationships and collaborates closely with Operations staff to keep them informed of progress of agreements and aligned on the relevant project timelines.
- Client Interaction: Participates in client meetings, presents reports, supports client relationships.
- Contract Planning: Develops contract management plans for site contracting projects.
- Knowledge Management: Develops and contributes to the knowledge database of sites, templates, processes regarding site contracting.
- Progress Tracking: Develops, improves, and maintains site contracting progress tracking and reporting with the use of appropriate tools, forms, or software.
- Contract Negotiation: Drives, negotiates, reviews, and processes contracts in a commercially reasonable manner that protects Avania's fundamental interests and in a manner consistent with company rules, practices, and policies.
- Contractual Terms: Negotiates contractual terms with other contracting parties.
- Obstacle Identification: Identifies potential obstacles in the contracting process promptly and requests assistance of Project Management staff as necessary to minimize delays and to facilitate the prompt conclusion of contractual negotiations.
- Administrative Support: Provides necessary administrative and operational support to bring and maintain the in-housekeeping at diligence-able level with respect to all site contracts.
- Training and Development: Supports in preparing internal training materials and presentations.
- Compliance: Liaises with DPO, IT, and other relevant stakeholders in an effort to ensure Avania complies with data protection laws and practices, taking into account GDPR, Australian Privacy Act, US HIPAA, and (international) data transfers.
Senior Associate Responsibilities
The key role of Senior Associate will be responsible for the following:
- Quality Control: Performs QCs on tasks performed by Associates.
- Mentorship and Support: Supports and mentors Associates.
- Process Improvement: Provides input and suggestions for improvement of processes, templates, playbooks, etc.
- Issue Resolution: Manages and resolves issues which may, depending on complexity, need escalation.
- Bid Defense Support: Provides support & input and participates in bid defenses' in collaboration with Business Development.
Candidates who offer a combination of the skills, knowledge, and experience listed below are encouraged to apply to our Senior Associate - Clinical Contract Management. With our continued growth, we are hiring talent to join us on our journey and grow with us.
We seek:
- Education: BA or MA legal, science, economics, business management.
- Experience: At least 2-4 year's experience in a similar role (Clinical or Site Contract Management gained in either sponsor and/or CRO).
- Contracting Knowledge: Proven site contracting knowledge (majority of topics and various countries) backed with strong contract management and budget negotiation skills.
- Project Management: Demonstrable project management skills, combined with the ability to work independently with limited guidance.
- Contract Review: Excellent contract review and use of playbooks skills.
- ICH GCP: Ability to apply principles of ICH GCP and follow quality standard procedures.
We offer:
- Opportunity: The opportunity to work in an innovative, fast-growing, and rewarding industry.
- Dynamic Team: A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties.
- Knowledge Sharing: Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities.
- Competitive Compensation: Competitive compensation and benefits package (details shared during the interview process).
- Travel Opportunities: Some roles offer the opportunities for travel.
- Remote Work: Ask us about our hybrid and fully remote work opportunities.
When you need to advance your career, it takes Avania.
We look forward to receiving your application.
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