• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work • Primary clinical point of contact with the client • Collaborate with PM on monthly invoicing and variance management of clinical budget • Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) • Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices • Generate potential site list from key stakeholders and drive site feasibility process • Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment • Develop and finalize the country recruitment/retention strategy • Develop timely and effective communication and good working relationships with investigators and study team • Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs • Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate • Support in planning and conducting investigator meetings • Review and/or approve of IP release packages • Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies for assuring study timelines are met • Generate and utilizes metric reporting to ensure that the study is conducted per plan • Responsible for eTMF implementation and management • Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) • Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits • Work closely with PM for project-specific resourcing issues • Escalate pertinent CRA performance and site compliance issues when necessary • Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines • Manage processes for investigational product (IP) including drug accountability and reconciliation • Support business development and marketing activities as appropriate