Sr Manager, Early Planning & Patient Recruitment

Integrated Resources, Inc

Cambridge, Massachusetts

JOB DETAILS
JOB TYPE
Contractor
SKILLS
Clinical Research, Clinical Trial, Clinical Trial Management, Communication Skills, Content Delivery/Distribution, Contract Research Organization (CRO), Customer Training, Data Collection, Data Processing, Employee Retention, Feasibility Analysis, Identify Issues, Information Technology & Information Systems, Logistics, Medical Records, Operational Strategy, Patient Assessment, Process Development, Process Improvement, Program Planning, Project/Program Management, Rehabilitation Nursing, Site Evaluation, Startup, Strategic Planning, Time Management, Vendor/Supplier Management, Vendor/Supplier Planning, Vendor/Supplier Relations, Vendor/Supplier Selection
LOCATION
Cambridge, Massachusetts
POSTED
2 days ago
Sr Manager, Early Planning & Patient RecruitmentIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionLocation: Cambridge, MA Duration: 12+ Months (Possibility Of Extension)Key contributor to the accuracy of early program and study planning by developing and supporting processes related to patient recruitment and retention, patient and site input into Client protocols, protocol feasibility and investigator meetings across all GCO studies. Patient Recruitment & RetentionSupport program and study teams by providing input and guidance regarding recruitment and retention (R&R) vendor engagement; leverage experience to ensure R&R vendor provides sound plans for recruitment and retention of patients; ensures R&R vendor is trained on Client processes and requirementsProvide continuity and connectivity between existing program/study feasibility efforts and development of recruitment and retention plans by R&R vendorSupport overall study planning by confirming R&R vendor is leveraging feasibility outputs, patient input and other available information when developing patient recruitment and retention strategyEnsure R&R vendor incorporates MOA findings into country-specific recruitment & retention plansSupport the COS/COL by identifying issues, barriers, etc., to successful recruitment and retention of patients and confirm these are addressed by the R&R vendor early in strategy developmentDirect R&R vendors and team members regarding efficient and timely review of recruitment & retention materials by mPRC/DRCSupport the COL and QCPM by advising as to the internal process for engaging R&R vendor in delivery of study-specific strategic and tactical plans for recruitment and retentionLead process improvement across the R&R space; provide ongoing assessment and input regarding quality of deliverables and performance of R&R vendors; assure strong R&R vendor supportPatient & Site Input into Client ProtocolsIdentify & manage vendor(s) and develop process to support study teams regarding the assessment and incorporation of patient input into Client protocols to influence study design and early operational strategy with the goal of generating data to support executable, patient-friendly study designs and assessmentsSupport COL/QCPM in obtaining site personnel input regarding the operational feasibility of a study, when necessaryCollaborate with COLs to advise on options for gathering of feasibility data and to manage the processIntegrate EPR efforts with Client Advocacy to identify Patient Advocacy Groups who can provide patient/caregiver input/perspective on study design and study burden; develop methods to assess patient and site burden of schedule of assessments e.g., duration of visits, frequency of visits compared to SOC, questionnaire volume / survey fatigue, etc.Ensure CRO Partnership standard processes are evaluated and implemented (e.g., patient journey, etc.)Collaborate with site/patient engagement efforts in the Clinical Country Management groupProtocol FeasibilityEvaluate opportunities for improvements in study feasibility process across studies within the CRO Partnership model (e.g., competitive landscape, country & site allocation plan, etc.); ensures the data and processes utilized for study start-up and enrollment plans from partner and other external vendors are effective.Ensure CRO Partnership study teams have optimal feasibility processes and data to inform decisions and plans.Evaluate if additional sources of information outside of the CRO Partnership (e.g., IMPACT, TA-Scan, B-Q study data, etc.) should be incorporated in to the standard processInvestigator Meeting SupportLead process development for interface with preferred vendor for investigator meetings across GCO studiesEvaluate innovative approaches to investigator meeting content delivery and support COL in implementation of viable optionsEvaluate and champion maximizing efficiency within the CRO Partnership for quality and consistency of logistics.Qualifications:Scientifically and clinically astute with very strong project management and communication skills.Approximately 8 years of clinical research / project management experience including clinical site and CRO or sponsor experience.B.A. or B.Sc. in a scientific discipline; advanced degree preferred.

About the Company

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Integrated Resources, Inc