Job Opportunities API

Position Summary:   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 and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.    Essential functions of the job include but are not limited to:    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 including presenting these at Investigator Meetings and Study Kick-off meetings  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 to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures   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 in conjunction with regulatory departments as applicable  Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables   Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate  Responsible for eTMF implementation and management   Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure   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   When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed  Support business development and marketing activities as appropriate   May negotiate site budget and investigator contract with support from the legal department and/or site contracts group  May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan  May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM  May perform clinical data review of patient profiles, data listings and summary tables, including query generation  May have line management responsibilities  Performs other duties as assigned by management  Qualifications:   Minimum Required: