Lead CRA CRO Oversight Manager

Location: Remote Opportunity with 30-50% Travel

Job Summary:

Lead CRA/CRO Oversight Manager will provide support on two or more Oncology studies and provide leadership on site/CRO oversight activities to ensure successful study completion. Working in support of the Clinical Trial Manager, the Lead CRA/Oversight Manager will ​be responsible for sponsor monitoring oversight activities and overseeing quality of trial deliverables to ensure the effective and efficient delivery of the operational aspects in accordance with the Clinical Plan, The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) standards, Scorpion Therapeutics Standard Operating Procedures (SOPs), local operating guidelines and local regulatory requirements.  There will be plenty of opportunities to own stretch projects that will help develop Project Management skills to support individual career growth.

Role Responsibilities/Accountabilities:

In this position, you will be primarily accountable for:

• Overseeing global site activations & monitoring. Support CTM in all regions (US, EU, APAC)
• Develop oversight processes and tools to maintain oversight of CRO field CRAs (e.g., dashboard to maintain oversight, perform site and CRO trending and risk assessments and trending across trials). Provide guidance for oversight activities across trial phases.
• Prepare and conduct sponsor oversight visits. Follow up with identified findings to CRO and responsible Clinical Trial Manager.
• Owner of trial oversight issue management processes (e.g. PD trending across trials to address any cross-trial issues with trial set-up, monitoring or site issues).
• Develop relationships with counterpart at CRO for managing CRAs & other supporting site engagement staff (ACRAs and other start up team members). Give input into resourcing & CRA allocation. Review CVs and approve of dedicated CRAs. Responsible for setting expectations for site start up and monitoring activities conducted by CRO.
• Owner of and responsible for developing and maintaining CRA training ensuring alignment with general training materials/sessions. Coordinate and participate in initial trainings & lessons learned ad hoc trainings (based on trending in oversight findings or audit/inspection findings) of CRA and other vendor staff.
• Work closely together with CRO & internal stakeholders to standardize central/remote monitoring processes.  Applies root cause analysis, critical thinking and problem-solving skills to identify processes failures and corrective/preventive actions to bring the CRAs and or sites into compliance and decrease risks.
• Provide support to CRO & CRAs with FAQs, GCP advice, site audits/inspections by organizing responses & guidance from internal SMEs.
• Support the development of CRO Oversight Plans specific to the trial as well as department level SOPs that govern quality trial deliverables.

 In this position, you will be responsible to:

• Participate in regular CRO project team meetings and internal cross functional trial team meetings.
• Perform retrospective review of visit report and follow-up letters according to oversight plan and maintain site engagement trackers.  Participate in the review of CRO developed site reference materials (e.g. ePROs, Pharmacy Manual, Regulatory Binder, Informed Consent Form, Patient Facing Materials etc.) Oversees CRO set up and management of Trial Master File.
• Assist CTM in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as site and country budget templates, case report forms (CRFs), EDC systems, IRT, central/specialty lab, ECG, imaging, drug supply, biomarker/sample management plans, TMF, and CSRs.
• Implement study plans, including vendor oversight, risk, quality, safety, and communication. Maintain oversight monitoring plans, templates, forms, and standard slide deck templates (with minimum monitoring requirements for SIV, pharmacy, etc)
• Support EDC, IRT and Clinical Trial Management System (CTMS) systems and data maintenance.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Perform invoice review against work completed on a monthly basis in relevant areas of oversight, i.e. passthrough costs associated with monitoring. 
• Support CTM in preparation & review of CRO & other vendor RFPs, SOWs & contracts.
• Utilize outputs from operational analytical tools to enhance and improve study execution.
• Contribute to study site selection and management.
• Assist with protocol, country, and site feasibility assessments.
• Assist with all activities related to site selection, contracting, set-up and maintenance.
• Assist with development of site budget template and contribute to site budget negotiations in collaboration with CRO for initial contract and all amendments.
• Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness.
• Assist CTM with planning and execution of effective investigator meetings in collaboration with CRO. As appropriate/applicable, contribute to the development of agenda and content for investigator meetings.
• Ensure study adherence to ICH/GCP and SOPs.
• Stay current on relevant Oncology drug development and clinical research best practices.

Skills:

• Proven track record of meeting or exceeding objectives and goals.
• Understand Sponsor/Site/CRO set-up and ways of working from a monitoring and oversight perspective. Experience in the detailed understanding of processes linked to successful site management/monitoring.
• Experience mentoring junior operations staff (i.e. CTAs or ACRAs).
• Demonstrable abilities to work independently (with less guidance and supervision) in trial conduct, process development, document management, risk assessment, training, and team management.
• Strong leadership, interpersonal & partnering skills: has proven abilities to work effectively and efficiently with cross-functional team members, CROs, vendors and consultants.
• Good process management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget delivery.
• Good communication, presentation & collaboration skills. Communicates in a timely, thorough, and concise manner and is comfortable presenting information to others internally and externally.
• Understanding cultural differences and diversity, able to work in a global setting with different internal and external stakeholders.
• Global experience preferred.
• Proactive stakeholder communication and experience with how to conduct difficult conversations.

Background/Experience and Education:

• Bachelor’s degree required* (science related discipline preferred).
• Association for Clinical Research Professionals (ACRP) Professional Certification (CCRA or ACRP-CP) a plus.
• Oncology Phase 1 global experience is preferred.
• Experience working with or for a Contract Research Organization (CRO).
• A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting is required.
• A minimum of 2 years of on-site oncology monitoring experience is required.
• Strong knowledge of operational aspects of clinical trial management and the drug development process.
• Strong knowledge of ICH-GCP and other relevant standards and guidelines
• Remote position, must be a US resident.
• Approximately 30-50% travel required to research sites, investigator meetings or vendor meetings. International travel may be required.

Tags