Clinical Project Lead
121 Seaport Boulevard Greater Boston Area, MA
Position: Clinical Project Lead
Job Location: Greater Boston Area, MA
Interview: Phone & In Person Interview
Duration: 12 Months
- The Project Manager Country Operations (PMCO) is responsible for the successful execution of study deliverables and the quality execution of protocol procedures, adherence to good clinical practices (GCP) and evolving regulatory requirements, and ensure quality and consistency of monitoring activities.
- The PMCO will be responsible for coordinating rapid start up activities across assigned countries together with the CRO. The PMCO will also drive adherence to timelines and milestones of study goals as well as identifying and communicating risks to the study team
- The PMCO will ensure that the CRO, FSP CRA or in house CRA performing monitoring activities at study sites results in the effective identification and problem solving of issues. Findings and solutions will be communicated to the CRO.
- Works with the CRO to revise study specific country plans and timelines including driving recruitment to ensure performance expectations are met. Ensures that the studies assigned in the country are appropriately and assesses CRA performance.
- The PMCO will also ensure that the CRO understands complex protocol processes and procedures and may support CRA protocol-specific training.
- Accountable for all country deliverables including driving recruitment
- Act as country level point of contact for the site: develop and maintain productive relationships
- Provide feedback to Internal and External Stakeholders as appropriate
- Proactively oversee startup processes to ensure expeditious startup of studies. Work with CRO to overcome roadblocks and issues that may delay site initiation and activation.
- Manage the study feasibility process
- Develops close relationships with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
- Develop and maintain tracking tools
- Review ICF country adaptations, Ethics Committee and Regulatory questions to resolve issues locally.
- Reviews/approves budget within the framework.
- Works with local regional legal on contract negotiation (e.g.Clinical Trial Agreements, Pharmacy Contract, Loan Agreement)
- Ensure that if required sites are provided with additional staff, ensures sites receiving equipment as needed to perform the study. Ensures that at startup it is clear which contracts are required for which site (e.g., LOII …
- Accountability for country level clinical study budgets as applicable
- Anticipates, recognizes and manages issues and understands when decision making can occur at local level or requires escalationot the study team
- Drives quality efforst to proactively identify and manage risks to study quality
- Review visit reports (or output of CRO report review) from site qualification, initiation and monitoring visits as applicable
- Communicate important clinical site assessment information to the study team and CRO
- Partner with Clinical Operations and Research staff to become knowledgeable on protocol procedures and requirements
- Leads Country Calls and meetings with the CRO and other internal meetings as applicable
- May assist or lead study-related training of CRO personnel, particularly CRAs, and study site team members
- Support inspection readiness and site preparation activities in the event of a regulatory authority inspection in partnership with the Quality function. Interface with regulatory inspectors, as needed.
- Remain current with GCP and global regulatory requirements and have working knowledge of local/regional regulatory requirements for assigned regions
- Proven experience in the oversight and delivery of operational aspects of all stages of of clinical trial process
- Solid knowledge of clinical development processes
- Ability to lead, troubleshoot and influence for quality and delivery
- A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
- Proven experience in effectively communicating with site staff including and including KOLs and thought leaders
- Comprehensive and current regulatory knowledge, including GCPs
- Experience conducting GCP or other training is a plus
- Demonstrates flexibility in schedule and willingness to travel frequently in assigned region (required travel may be as high as 30% during busy periods)
- Good organizational skills and ability to deal with competing priorities
- Effective communication skills (written, verbal and presentation)
- Creative thinker, curious and unafraid to ask questions
- Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
- Proficient with MS Office Suite (Excel, Word and PowerPoint).
- Bachelor' s Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred.
- 5+ years of relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred
- Experience in all study phases and in rare medical conditions preferred
- Previous oversight and regulatory inspection experience preferred