Clinical Contracts Analyst (60852)

Clinical Contracts Analyst

BIOTRONIK is one of the leading manufacturers of cardio and endovascular implants and catheters for cardiac rhythm management electrophysiology and vascular intervention. As a globally active company headquartered in Berlin Germany we develop produce and distribute highquality medical products based on the latest technology and research. Our success is based on the competence and resultsoriented cooperation of our employees.

The Clinical Contracts Analyst will develop and negotiate contracts and budgets associated with clinical trials ensure contracts comply with regulations manage the lifecycle of contracts and process clinical trial payments.

Your Responsibilities:

• Facilitate negotiation execution and ongoing revisions of clinical study contracts based on substantial knowledge of financial/fair market value regulatory and clinical requirements while demonstrating clinical knowledge. Recommend new/or revised language for contract templates
• Function as the primary internal and external contact for contracts and payments
• Assure compliance with existing agreements and analyze need for contract amendments or renewals and make recommendations and/or negotiate changes to terms and conditions
• Facilitate and direct internal legal review of contract language as appropriate
• Maintain contract negotiation correspondence and agreements in accordance with procedures
• Monitor changes to regulatory and legal requirements affecting clinical study contracts and reimbursement practices
• Provide proper escalation of contractual and payment issues and actively engage with management to provide recommendations for mitigation
• Manage the clinical compensation process database and related reporting including issuance of payments for investigator fees IRB oversight and other reimbursable costs for clinical trials
• Manage contractual and financial information in clinical trial databases with high degree of accuracy
• Provide data management analytics reporting and business intelligence support for clinical trials
• Track timelines and ensure contract and compensation requirements are met in coordination with project team expectations
• Develop study compensation agreement template with support from project managers and management and obtain necessary approvals
• Ensure consistency with the study protocol clinical contract template informed consent language and compensation agreement.
• Collaborate with project team members on development and testing of study payment programming
• Interface with Finance and Accounts Payable as needed on payment inquiries
• Regularly communicate contract and/or compensation agreement negotiation and execution status to the project team and clinical management
• Develop and/or negotiate investigatorinitiated research contracts data use agreements thirdparty vendor clinical research contracts and clinical consulting agreements upon request.
• Perform other duties as assigned
• Identify opportunities for process improvement in collaboration with crossfunctional teams; present and implement process improvement plans to management and/or key stakeholders.

Your Profile

• BBS/BA in related field or equivalent experience
• Minimum of 2 years experience in contract negotiation/administration and financial tracking/analysis against contracts
• Experience in clinical research and related regulatory requirements
• Advanced written and verbal communication skills and interpersonal relationship skills
• Proven problemsolving organizational analytical and critical thinking skills
• Ability to work independently prioritize and work within a matrix team environment is essential
• Clinical contract work experience from pharmaceutical medical device healthcare or Contract Research Organizations (preferred)
• Understanding of regulatory requirements (e.g. CFR GCP) and documents
• Moderate knowledge of the clinical research process medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
• Proven expertise in Microsoft Office Suite including Word PowerPoint Access Excel and SharePoint electronic data capture
• Basic understanding of relational databases including query design file manipulation table structure
• Ability to work in a team environment and represent the organization on specific projects
• Experience with contractual agreements including master services agreements (MSAs) statements of work (SOWs) data use agreements (DUA) nondisclosure agreements (NDAs) and amendments.
• Ability to professionally negotiate financial and contractual terms
• Ability to build and maintain productive internal and external working relationships
• Quality driven strong attention to detail positive attitude and enthusiastic toward work
• Ability to interact professionally with all organizational levels

Travel

• Minimal travel expectations but must have willingness and ability to travel domestically and internationally as required less than 10% of the time

Location

• Hybrid out of our Lake Oswego Oregon campus or remote within the United States based on skill set and qualifications.

Are you interested Please apply online through our application management system! We are looking forward to welcoming you.

Location: Lake Oswego OR Working hours: Fulltime Type of contract: Undefined

Apply now under: ID: 60852 BIOTRONIK Inc. United States (US)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion age sex sexual orientation gender identity or expression national origin disability status protected veteran status genetic information or any other characteristic protected by law. Please note that applications sent by post will only be returned if a sufficiently stamped selfaddressed envelope is included.