BIOTRONIK is looking to add a Clinical Contracts Analyst to our Clinical Studies team. The Clinical Data Operations (CDO) group is responsible for providing the company’s data management services and contracts support related to our clinical trials. The Clinical Contracts Analyst is responsible for negotiating the compensation and contractual terms required to partner with health care providers participating in clinical trials research sponsored by BIOTRONIK, Inc.
- Facilitate the initial negotiation, execution, and ongoing revisions for clinical study contracts with health care providers
- Function as the primary point of contact both internally and externally for contracts pertaining to all clinical study centers
- Facilitate and direct internal legal review of contract language as appropriate
- Assure compliance with existing agreements and ensure proper routing of documents for full execution by management and outside parties
- Maintain files of contract negotiation correspondence and provide final executed contracts to the project team.
- Keep informed of changes to regulatory and legal requirements affecting clinical study contracts and reimbursement practices
- Provide proper escalation of contractual issues to Clinical Studies Management
- Manage the clinical compensation process, database, and related reporting, including issuance of payments for investigator fees, IRB oversight, and other reimbursable costs for clinical studies
- Manage 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
- Interface with Clinical Data Analysts to develop payment schedule and trigger specifications based on eCRF and support testing/ validation of specification programming
- Perform data entry and direct QC by the CRA group of site-specific compensation milestones within the Compensation Database
- Interface with Finance and Accounts Payable as needed
- Attend and engage in scheduled project team meetings
- Regularly communicate status of clinical site’s progress towards contract and/or compensation agreement completion to the project team and clinical management.
- Support project managers and clinical management with compensation agreement development and Financial Grant Committee documentation submission content
- Review the study protocol, clinical contract template, informed consent language and compensation agreement for language consistency.
- Generate or provide input in the development and/or negotiation of investigator initiated research contracts and third-party vendor clinical research contracts, upon request.
- Perform other duties as assigned
- Knowledge of the clinical research process
- Experience in contracts administration for clinical trials
- Ability to understand and further develop effective contractual language
- Ability to professionally negotiate financial and contractual terms
- Ability to build and maintain productive alliances and partnerships with internal and external clients
- Quality driven, positive attitude and enthusiastic toward work
- Strong communication skills (verbal and written) to express complex ideas
- Excellent organizational and interpersonal skills
- Ability to interact with all levels of staff to coordinate and execute study activities
- Understanding of essential data processing systems, including electronic data capture
- BS/BA in life sciences or equivalent experience
- Minimum of 2 years experience with contracts administration for clinical research
- Knowledge of clinical research and related regulatory requirements
- Basic understanding of relational databases, including query design, file manipulation, table structure
- Excellent verbal and written communication skills
- Demonstrated problem solving skills
- Ability to work independently, prioritize and work w
- Minimal travel expectations but must have willingness and ability to travel domestically and internationally as required less than 10% of the time
To apply for this job please visit career012.successfactors.eu.