Job details
Job type full-time
Full job description
Overview: health decisions is a specialty cro that utilizes a broad expertise across women’s health research with adaptive design and adaptive operational capabilities to deliver medicines and diagnostics of value to women worldwideWe are seeking a clinical trial lead that independently monitors the clinical monitoring team (clinical research associates [cras], clinical trial associates [ctas] and other clinical support staff, to ensure that projects are completed in accordance with applicable regulations and guidelines, client expectations, and health decisions standards and processesThis position is responsible for providing direction to and training for clinical operations staff assigned to those projectsThe ctl is responsible for the oversight of all operational aspects related to the planning and management of clinical operations (scra, cra, cta) and site performanceThe ctl will be responsible for ensuring that sites and clinical operations operate in compliance with study protocols, ich/gcp guidelines, and federal regulationsResponsibilities:
Working collaboratively with project managers (pms) to proactively drive project success
Assisting pm with managing resource and utilization assessments, timeline adherence, quality assurance, and financial adherence as it pertains to clinical monitoring team activities
Acts as secondary sponsor contact on studies with a pm lead; may serve as project manager on certain studies.
Operational aspects of planning and management of site performance in accordance with departmental productivity expectations
Creating, reviewing, and modifying study documents, including study management plans, processes, and templates, as needed
Developing and implementing enrollment strategies
Determining and driving the study start up process (track and report progress, review data), ensuring that all sites are selected and supplies provided in accordance with study start expectations
Providing status updates to pms and sponsors
Planning and facilitating clinical team meetings/teleconferences
Tracking monitoring activity projections, including resource and visit projections
Creating and conducting training sessions including investigator meetings, conferences, team and hd internal trainings
Supporting the management and development of other cras
Training other cras during co-monitoring visits
Acting as a resource and point of escalation for protocol and process questions from clinical monitoring team members as well as clinical site staff.
Providing skilled review of study protocols and other study materials (e.gCrf)
Working effectively with site study coordinators
Planning and facilitating site teleconferences, if applicable
Reviewing monitoring visit reports and ensuring finalization is within contractual timeline.
Identifying and documenting deviations if applicable
Reviewing and approving expense reports
Participating in the rfp, proposal, and bid defense processes, including internal and external business development meetings, as needed
Participating in the clinical operations community at hd by
Assisting or leading key internal initiatives and standard operating procedures for the administration and monitoring the clinical trials
Escalating study issues appropriately to pms, and clinical operations leadership, as applicable
Providing feedback on clinical team member performance to line managers.
Qualifications: the successgul candidate will hold a bs/ba degree and clinical monitoring experience with a minimum of 5 years of collective experience within the cro, pharmaceutical, or biotechnology industry with site facing responsibilities, with at least 2 years of on-site monitoring experienceSuperior written and oral communication, organization, and presentation skillsStrong leadership skills and demonstrated ability to work cooperatively with othersStrong mentorship skills and demonstrated in-depth knowledge of monitoring practices and standards to ensure quality of monitoring for the clinical teamBroad range of therapeutic experience, women’s health experience beneficialDemonstrated ability to train, mentor, and lead clinical research staffThe ability to constructively interact directly with sponsor personnelProgressive experience in the conduct of clinical research including ich-gcp requirements, drug/device development process, and regulatory complianceThis position requires approximately 30% travel
Health decisions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
