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Northwell Health · 3 months ago

Senior Clinical Research Program Manager

972 Brush Hollow Road, Westbury, NY, 11590, US

Full-time

Onsite

Mid, Senior Level

$66K/yr - $108K/yr

3+ years exp

Northwell Health is a healthcare organization that is seeking a Senior Clinical Research Program Manager to oversee research administration at clinical sites. The role involves managing clinical research sites, ensuring compliance with protocols, and providing training and support to team members.

ConsultingHealth CareHealth DiagnosticsMedicalPublishing

Responsibilities

Trains, coaches, supports and mentors Site Clinical Research Managers and other team members

Manages the clinical research sites including, but not limited to acting as primary contact for clinical research sites for questions related to the protocol conduct protocol, regulatory document completion, study supplies, client scheduling, and electronic data capture

Provides on-site or remote monitoring of clinical research site activities to ensure compliance with protocols, SOPs and relevant federal and state regulatory and institutional policies

Provides consultation during study start-up activities regarding development of study protocol, SOP or Case Report Forms (CRFs), site qualification, data collection and study conduct

Patricipates in site initiations and trainings

Assesses accuracy, completeness and timeliness of study records by performing source data verification, regulatory document and consent form review, adverse event reporting compliance review, and investigational product accountability

Performs study close-out monitoring activities

Provides pre-review assistance prior to regulatory inspections and submissions

Provides guidance on regulatory submissions to the FDA which may include an Investigational New Drug (IND), Investigational Device Exemption (IDE), New Drug Application (NDA) or other research under the purview of the FDA

Prepares and forwarding monitoring reports to program manager. Working with study staff to address any concerns

Promotes overall compliance and quality with research conduct through participation in education and training activities for professional staff

Assists in developing appropriate education and training sessions for investigators and clinicians involved in research

Works on assignments that involve moderately complex to complex issues where the analysis of situations or data requires in-depth evaluation of variable factors

Regularly makes new recommendations on new processes, tools, and services that can impact multiple projects and other functions

May provide technical guidance and direction to support team members, contractors and/or other vendors

May serve as project/technical lead for ongoing processes or short-term projects within function or family

Performs related duties, as required

Qualification

Clinical trial managementRegulatory complianceData verificationProtocol developmentTeam leadership

Required

Bachelor's Degree or equivalent combination of education/related experience, required

3-5 years relevant experience, required

Company

Northwell Health

Glassdoor3.9

Northwell Health is New York State’s largest health care provider and private employer, with 28 hospitals, about 1,000+ outpatient facilities and more than 16,000 affiliated physicians.

Founded in 1997

Manhasset, New York, USA

10001+ employees