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Clinical Associate
Ref No.: 18-02565
Location: Cambridge, Massachusetts
Position Type:Contract
Start Date / End Date: 05/28/2018 to 12/21/2018
Job Title; Patient Recruitment & Retention Lead
Duration: 7 Months
Location: Cambridge, MA


Job Description:
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 Biogen 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 Clinical Program Lead (CPL)/Clinical Operations Lead (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 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 Biogen Protocols
Identify & manage vendor(s) and develop process to support study teams regarding the assessment and incorporation of patient input into Biogen 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 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 FERO efforts with Biogen 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

Now open the criteria up to a solid Clinical Operations Lead type background rather than requiring a Pt R&R Lead/Manager role. For expanding, we would require someone who has experience with patient R&R as part of their Clinical Operation Lead role, but may not have be accountable/lead of the pt &R campaign. By broadening we would seek someone who has extensive exp with managing clinical studies, managing vendors, working with cross functional team, global teams and studies. Someone who is comfortable taking on new areas of work and lead proactively.

Must Haves:
-Experience building the strategy and execution of patient recruitment and retention campaigns for clinical studies.
-Need a minimum of 8 years of experience, specifically in the patient recruitment and retention campaigners.
-Experience in CRO
-Experience in managing the patient recruitment and retention strategies
-Experience in working with vendor and clinical sites

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:
Approximately 8 years of clinical research / project management experience including clinical site and CRO or sponsor experience.

Education:
B.A. or B.Sc. in a scientific discipline; advanced degree preferred. Scientifically and clinically astute with very strong project management and communication skills.
Experience building the strategy and execution of patient recruitment and retention campaigns for clinical studies.