Precision Medicine Group · 14 hours ago
Study Enrollment Lead
Remote, United States
Full-time
Remote
Mid, Senior Level
$108K/yr - $162K/yr
4+ years exp
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Responsibilities
Support the development and execution of site enrolment strategies and tactics appropriate to the awarded study needs and in alignment with sponsor requirements:
Successfully deliver training to all current and onboarding Precision for Medicine CRAs and CTMs on effective study recruitment and retention communication with site staff
Coach CRAs on an ongoing basis to ensure successful implementation of skills learned during recruitment and retention training. This could be in a group or a 1:1 environment, depending on the needs of the individual, study and/or sponsor.
Train CRAs on all elements of the patient engagement strategy in partnership with the Senior Patient Engagement Lead prior to each study’s first SIV. Depending on the scope of the strategy, this could include:
Patient profile, including their needs, views and experience based on patient feasibility results
Patient advocacy group engagement strategy
Patient and site-facing awareness, education, engagement and support tools
Diversity, equity and inclusion goals and associated strategy
Lead the organization to ensure that every site on every new and ongoing study has a site recruitment plan in place (excluding first in human trials) and that it is revisited with the site either quarterly or sooner if recruitment begins to lag. To facilitate this, the SEL will lead creation and implementation of the following, supported by their Patient Engagement colleagues and Operational Excellence:
Align stakeholder colleagues with the goal
Map and implement the process for capturing and managing site recruitment activity
Ensure ongoing availability and utilization of accurate data to track compliance
Liaise with CTMs to ensure their effective oversight of this activity by CRAs to ensure compliance
Partner with Project Management to ensure that recruitment data is effectively surfaced and incorporated into their enrolment management and projection activities
Plan for implementation of an automated process for data capture and surfacing, for deployment in Q2 FY25
Work as an SME for project teams to troubleshoot recruitment and retention challenges on ongoing trials.
Recommend patient engagement strategies for rescue studies, from either or both of the following:
Site-based communication support for CRAs
Broader strategies to facilitate site referrals, outreach, patient education etc., devised in partnership with the Senior Patient Engagement Lead.
Communicate with sponsors and project teams to implement and monitor impact of study enrolment tactical plans. Make additional operational and tactical recommendations as needed based on study performance.
Represent Precision for Medicine at site/sponsor-facing meetings e.g., KOMs, IMs, to present strategy/rationale, train site staff, and conduct recruitment support workshops as required.
Contribute to bid defense meeting prep and attend bid defense meetings, particularly where study enrolment support is required.
Maintain knowledge of current site and patient engagement trends, vendors, and technologies to increase productivity and recommend additional support as needed.
Develop and implement risk management plans
Provide technical expertise in support of project specific and interdepartmental training efforts
Contribute to thought leadership activities as needed
Support continued process improvement to ensure quality in the department.
Other responsibilities as mutually agreed
Qualification
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Required
Advanced degree in life sciences discipline or equivalent experience
4 years or more as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.
Significant site management experience or equivalent experience in clinical research
Extensive experience in clinical development focused on strategy and execution of all phases of clinical trials
Strong strategic and analytical thinking
Ability to prioritize critical needs
Extensive experience with MS Word, Excel, and PowerPoint
Fluency in English
Highly capable of motivating other members of the project team to meet timelines and project goals.
Experience monitoring in rare and complex therapeutic areas
Experience monitoring EDC trials and EHR records
Experience in biopharma or relevant therapeutic area
Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
Ability to resolve project-related problems and prioritize workload to meet deadlines with oversight from management.
Can assist junior CRAs in problem resolution
Strong sense of ownership and pride in quality of outputs
Self-starter, comfortable with a lack of structure, ability to build processes and engage colleagues in new ways of working
Skilled at working in a matrix environment, independently and as part of a dynamic team and in a decentralized reporting model (as applicable).
Exhibits self-motivation and is able to work and plan independently as well as in a team environment.
Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, deliver positive interactions with customers and teammates, including good interpersonal skills.
Collects data of consistently high standard.
Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
Demonstrated ability to motivate other members of the project team to meet timelines and project goals.
Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
Demonstrated ability to identify training needs and develop project-specific training plans to address those needs.
Demonstrated basic understanding of financial management.
Fluency in English and for non-English speaking countries the local language of country where position based
Domestic and international travel including overnight stays
Preferred
Graduate, postgraduate degree
Benefits
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.
Founded in 2012Bethesda, Maryland, USA
1,001-5,000 employees
Funding
Current Stage
Late StageLeadership Team
Mark Clein
Co-Founder & Chief Executive Officer
Matt DeZee
Chief Financial Officer
Company data provided by crunchbase
