Study Enrollment Lead

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Study Enrollment Lead?

Position Summary:

The Study Enrolment Lead (SEL) has wide-ranging and broad experience successfully communicating with site staff to optimize trial enrolment. The primary responsibility of the Senior SEL will be as SME supporting CRAs with site-based recruitment activities appropriate to any awarded study expectations and in alignment with sponsor requirements. Focus is on coaching CRAs to enable them to have clear and effective recruitment discussions with sites and ensuring that they have active site recruitment plans in place that are aligned to study goals, to help keep enrolment on track.

This role is a key position, requiring successful collaboration with colleagues, particularly Clinical Operations and Project Leadership, to effectively manage the planning, coordination, quality and implementation of site recruitment plans across all Precision trials. It will also involve strong training and coaching of CRAs for successful translation of Precision expertise into meaningful impact on the conduct of our studies.

Essential functions of the job include but are not limited to:

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

Qualifications:

Minimum Required:

• Advanced degree in life sciences discipline or equivalent experience

Other required:

• 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

Preferred:

• Graduate, postgraduate degree

Skills:

• 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 resolves project-related problems and prioritize workload to meet deadlines with oversight from management. Can assist junior CRAs in problem resolution

Competencies

• 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

Travel Required

Domestic and international travel including overnight stays

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