Drive country-level performance and compliance across assigned clinical trial protocols, taking ownership of clinical study start-up, budget formulation, contract negotiation, and regulatory approvals.
Locations (2)
London, England, United Kingdom
Rahway, New Jersey, United States
Responsibilities
Lead the development, negotiation, and execution of Clinical Trial Research Agreements (CTRAs) and site budgets within fair market value.
Oversee trial financial tracking, payment reconciliations, milestone tracking, and financial compliance (including FCPA and anti-corruption requirements).
Direct country-level regulatory authority and IRB/IEC submissions and approvals for assigned protocols.
Ensure all local language materials, patient-facing documents, and informed consents are accurately translated and compliant with ICH/GCP and local laws.
Partner closely with Clinical Research Associates (CRAs), Clinical Trial Coordinators (CTCs), Finance, and Legal to remove bottlenecks and achieve milestone readiness for trial sites.
Provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.
Responsibilities
Support the clinical team’s inhouse activities on assigned projects
Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF)
Support the clinical team in essential document development, collection and management process
Manage the Clinical Trial Management System (CTMS)
Create the Investigator Site Files, co-ordinating the ordering, dispatch and tracking of trial materials
Requirements
Relevant experience/qualifications in Life Sciences or related field or administration
Lead the implementation of Risk-based Quality Management across studies, develop dashboards, reports, and visualizations to oversee data integrity and risk indicators.
Responsibilities
Single point of accountability to embed RbQM aligned with study planning
Ensure monitoring mitigations to study and data risks are fit for purpose
Work with Operations team to define oversight plan
Work with Data Management to ensure fit for purpose automated and manual cleaning checks
Work with Clinical Trial Manager to define CRA strategy
Requirements
Bachelor's Degree in Science related field or equivalent work experience
Responsible for the successful planning, implementation and execution of contracted activities for early clinical development studies, ensuring compliance with Good Clinical Practices and client requirements.
Locations (2)
Florissant, Missouri, United States
United States
Compensation
The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Responsibilities
Plan, implement and execute contracted activities for clinical studies
Assure accurate transfer of contracts from proposal through project completion
Lead project teams throughout clinical trial duration
Maintain client relationships and clear communication
Negotiate with clients to maintain operational processes
Responsible for the successful planning, implementation and execution of contracted activities for clinical trials, ensuring accurate transfer of contracts, client communication, and compliance with Good Clinical Practices.
Compensation
The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Responsibilities
Plan, implement, and execute contracted activities for clinical trials
Transfer contracts from proposal through project completion
Lead project teams for regional and global projects
Build and maintain client relationships
Negotiate with clients to maintain operational processes
Requirements
Bachelor's degree in a health-related field
Nice to have: prior experience in electronic data capture
Lead the start‑up and site activation activities for clinical studies in Australia, coordinating ethics submissions, documentation, and regulatory requirements to bring new medicines to patients.
Responsibilities
Coordinate ethics and regulatory submissions
Manage site activation plans and risk mitigation
Collaborate with cross‑functional teams
Track start‑up metrics and KPIs
Ensure compliance with GCP and local regulations
Requirements
Bachelor's Degree in health care or scientific field
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