Job Overview
Step beyond traditional monitoring and take on a highly visible, relationship-driven role where you can truly influence clinical trial success. In this unique hybrid role, you will lead proactive site engagement, build long‐term partnerships, and drive patient recruitment and retention through tailored strategies, while still maintaining oversight of site quality, compliance, and delivery. Working across multiple studies and collaborating closely with cross‐functional teams, you will play a critical role in shaping site performance, enhancing investigator experience, and ultimately accelerating the delivery of high‐quality clinical trials.
Site Engagement Manager Responsibilities
* Receives study‐specific requests and operational guidance from the Site Engagement Leads, Head of Site Engagement and Clinical Project Manager.
* Serve as the "face" of the client to develop/strengthen relationships with new/current clinical trial investigators and their research site staff to facilitate recruitment and retention of subjects in clinical trials on behalf of the Sponsor.
* Enhance clinical trial investigators' and their research staff's awareness of and relationship with the Client (including highlighting publicly available information regarding the Sponsor's mission, values, pipeline, etc.) through direct interactions and other mechanisms such as the Sponsor's website and social media.
* Function in accordance with the Client Code of Conduct, Standard Operating Procedures (SOPs)/Working Practices (WPs), and local/country regulations. The SEM may also contribute to the development and implementation of new SOPs/WPs as applicable.
* Be assigned up to approximately 20‐25 investigator sites on average and may be assigned to more than one trial at a time depending on factors such as the number of sites, trial stage, and concurrent trial participation.
* Serve as the primary point of contact between the organization and site personnel, fostering a sense of partnership and mutual benefit to enhance long‐term relationships with investigators and site staff.
* Maintain repeated interactions with clinical trial investigators and their research staff over the course of each trial to keep the trial on their "top of mind" via on‐site visits, virtual meetings, phone contacts, email, webinars, etc.
* Maintain clear and consistent communication channels with site coordinators, investigators, and staff; provide regular updates on trial progress and solicit feedback on protocol modifications and other relevant information.
* Develop tailored engagement plans and strategies for each investigator site to align with their specific needs and challenges.
* When required (e.g., critical escalations), collaborate with the client Study Team to ensure investigators and their site staff have a thorough understanding of the investigational agents, eligibility criteria, and all trial procedures.
* Understand how the trial fits into the site's treatment pattern and how competing trials or upcoming drug approvals may affect recruitment or conduct.
* Analyze patient enrollment and retention methods to identify potential roadblocks and propose strategies to increase recruitment and/or retention rates at each site.
* Identify potential risks associated with site performance and elevate issues to mitigate negative impact on trial timelines and outcomes.
* Escalate concerns related to compliance, regulations, and quality standards to support sites' adherence to study requirements.
* Relay to the study team any necessary training for site personnel on trial protocols, data collection, and reporting procedures; expedite resolution of questions or concerns.
* Regularly assess the effectiveness of engagement strategies and recommend improvements based on industry best practices and lessons learned.
* Collaborate with cross‐functional teams to ensure alignment of goals.
* Conduct or participate in site feasibility assessments/qualification visits and participate in Pre‐Selection Visits (PSVs) and Site Initiation Visits (SIVs) with the CRAs to evaluate investigators and staff capabilities for successful trial conduct and target achievement; share findings and recommendations with the Sponsor.
* Actively participate in investigator meetings as required.
* Identify potential new clinical trial investigators for the Sponsor through literature reviews, scientific/medical conferences, internet searches, and other sources.
* Participate actively in SE initiatives such as roundtables.
SCRA Key Responsibilities
* Monitor and manage clinical study sites, including initiation, routine visits, and closeout activities.
* Ensure patient safety and compliance with informed consent and protocol requirements.
* Review source documents and verify data integrity on Case Report Forms (CRFs).
* Prepare accurate and timely monitoring reports and maintain study files.
* Serve as a monitor for assigned protocols and assist in developing monitoring plans.
* Coordinate with vendors and internal teams to meet project timelines and objectives.
* Support feasibility assessments, budget negotiations, and regulatory submissions.
* Travel extensively (60–80%) to support site activities and maintain audit readiness.
Qualifications
* Bachelor's degree in life sciences or related field, or equivalent clinical research experience.
* Minimum 5 years of site engagement and clinical monitoring experience in a pharmaceutical or CRO setting.
* Strong knowledge of regulatory requirements and drug development processes.
* Advanced site monitoring and management skills.
* Excellent communication, organizational, and problem‐solving abilities.
* Proficiency in relevant computer applications and systems.
* Valid driver's license and ability to travel extensively.
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