This position will be responsible for the execution of clinical studies with our CRO vendors or partners in full compliance with company SOPs, good clinical practices, and applicable regulatory guidelines. The selected candidate will collaborate with senior management and other internal stakeholders to ensure appropriate fiscal oversight, including management of vendor scope-of-work and change orders.

Responsibilities Include:

• Execute the Clinical Development Plan with program oversight of all aspects of clinical operations budgets for studies.
• Manage the protocol drafting and amendment processes.
• Facilitate and participate in the selection and management of clinical outsourcing vendors.
• Oversee and direct all operational aspects of one or more clinical programs including project timelines, budgets, resource allocation/staffing, and management of contract research organizations (CROs) and other key vendors.
• Provide strategic input on the management and resourcing of future clinical trials, as needed.
• Assist project management in the development and tracking of project finances and staffing with direct responsibility for adherence to project timelines and budgets; must be able to anticipate deviations and inform management with proposed mitigation strategies.
• Oversee site management and monitoring activities.
• Work with the clinical sites and CRO to progress the clinical studies.
• Draft informed consent and other study documents.
• Oversee review of clinical data and associated metrics, and addresses data quality issues directly with CROs/monitors and sites as needed. Develops reports as needed to track monitoring visits.
• Provide vendor oversight and develop metrics and reports as needed.
• Provide updates to senior management.
• Oversee the creation of CSRs, SAPs, TLFs and other study documents.
• Assist sites IRB/Ethics Committee submissions and prepare responses to questions as required.
• Review and contribute to CSRs writing, INDs, NDAs, and other clinical and regulatory documents.
• Help prepare and manage study documents related to protocols, Investigator brochures, informed consent, pharmacy manual, safety management plans, and collaborating with experts.
• Support the regulatory group’s annual reporting for all clinical programs.
• Provide ongoing assessment and feedback on policies and procedures toward increased efficiency and quality of deliverables.
• Contribute to the development of SOPs and other procedural documents.
• Support clinical compliance activities and facilitates responses to auditors and satisfactory resolution of clinical quality issues.

Qualifications:

• BA/BS degree, preferably in the life sciences or related field.
• Minimum of 8 years’ clinical operations experience (large phase 3 studies preferred), 5 of which must be trial manager level or above, at a CRO or pharmaceutical/biotech company.
• Expert knowledge of cGCP, ICH Guidelines, and other relevant regulations and processes.
• Effective communication, organizational, interpersonal, and leadership skills.
• Proven expertise in anticipating and identifying issues, apply insightful analyses, and solve problems effectively.
• Ability to handle multiple tasks to meet deadlines in a dynamic business environment, with minimal supervision.
• Ability to understand, adapt, and implement best-practice systems and strategies for managing clinical operations and clinical project management tasks to support development goals.
• Ability to work effectively on a team in an entrepreneurial environment.
• Computer skills should include proficiency with Microsoft Office and ability to use remote office skills and tools.
• Ability and willingness to work with collaborators outside the US, possibly including regular conference calls early in the day or late in the afternoon/evening.