Sr Manager, Early Planning & Patient Recruitment

Job Title: Sr Manager, Early Planning & Patient Recruitment

Location: Cambridge, MA
Duration: 12+ Months (Possibility Of Extension)

Job Description

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 & Retention

·Support 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 requirements

·Provide continuity and connectivity between existing program/study feasibility efforts and development of recruitment and retention plans by R&R vendor

·Support overall study planning by confirming R&R vendor is leveraging feasibility outputs, patient input and other available information when developing patient recruitment and retention strategy

·Ensure R&R vendor incorporates MOA findings into country-specific recruitment & retention plans

·Support 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 development

·Direct R&R vendors and team members regarding efficient and timely review of recruitment & retention materials by mPRC/DRC

·Support 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 retention

·Lead 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 support

Patient & Site Input into Client Protocols

·Identify & 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 assessments

·Support COL/QCPM in obtaining site personnel input regarding the operational feasibility of a study, when necessary

·Collaborate with COLs to advise on options for gathering of feasibility data and to manage the process

·Integrate 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 group

Protocol Feasibility

·Evaluate 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 process
Investigator Meeting Support

·Lead process development for interface with preferred vendor for investigator meetings across GCO studies

·Evaluate innovative approaches to investigator meeting content delivery and support COL in implementation of viable options

·Evaluate 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.