Business Operations Mgr, Clinical Trials and Innovations
NateraSalary not specified
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, Clinical ResearchIndustries
Requirements
- Bachelor’s degree in related field
- 3 years’ experience and/or equivalent competencies in legal/pharmaceutical industry/clinical research
- Excellent communication skills (both oral and written)
- Familiarity with healthcare compliance and other relevant guidance
- Familiarity with clinical research processes
Responsibilities
- Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor’s requirements
- Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversight of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements
- Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions
- Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate
- Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required
- Participate in discussions related to the development of site/investigator budgets aligned with fair market value
- Manage the contract amendment lifecycle
- Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites
- Assume responsibility for all aspects of legal document and metrics tracking
- Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines
- Track all aspects of legal document and metrics. Determine potential needs for contract amendments and manage amendment lifecycle
Skills
Contract Negotiation
Clinical Trial Agreements
Legal Risk Assessment
Budget Management
Contract Amendments
Fair Market Value
Metrics Tracking
Pharmaceutical Industry
Clinical Research
IQVIA
Advanced analytics and clinical research services
About IQVIA
IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.
Durham, North CarolinaHeadquarters
1998Year Founded
$3,526MTotal Funding
POST_IPO_EQUITYCompany Stage
Cybersecurity, Biotechnology, HealthcareIndustries
10,001+Employees
