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- The Sr. Manager, Study Site Engagement is the local face of Client by contributing to an effective partnership between Client study teams, study sites and the Clinical Research Organization (CRO) (i.e., the Clinical Research Associate (CRA)). The Sr. Manager, Study Site Engagement establishes communication with regional/country Associate Director, Study Site Engagement, and the Medical Affairs (MA), provides updates on study/site status, and establishes site engagement study specific strategies.
- The Sr. Manager, Study Site Engagement supports study teams with trial operations from Feasibility through Clinical Study Report (CSR) within the assigned region or countries across Client therapeutic areas.
- The Sr. Manager, Study Site Engagement enhances engagement and offers added value by providing guidance and sharing knowledge with study sites, while establishing and nurturing long-term relationships with investigators and study site personnel. The Sr. Manager, Study Site Engagement supports country and site identification, feasibility, site selection, study start-up, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs.

Early engagement - Country and site feasibility

- Supports the Study Site Engagement Lead (SSEL)/ SSE Program Lead (SSE-PL)/SSE Study Lead (SSE-SL) with the development of study site list for feasibility - site selection and aids in tracking feasibility progress and escalations for SSEL/LOC support.
- Reports any discrepancy on feasibility progress to SSE-PL/SSE-SL
- Liaises with SSE-PL/SSE-SL, MA, local Clinical Operations team (if available) and CRO staff for site identification and feasibility support in alignment with global study team.
- Attends Pre-Study Visit (PSV)



as requested or agreed upon with the SSE-SL.
- Helps to follow up with country MA, local Clinical Operations team and keep track country and site selection activities.

Study startup phase - Post site selection to site initiation

- Supports the SSE-PL/SSE-SL in tracking start-up hurdles escalated to the team and their resolution to ensure Site Initiation Visits (SIVs) and site activations are achieved as planned.
- Attends and/or supports SIVs.
- Helps SSE-PL/SSE-SL in tracking resolution of any follow-up item needed post SIV until resolved by site and or CRO/Client study team.
- As invited, attends Investigator Meetings (in the region) and liaises with sites / CRO.

Enrollment and study conduct phase

- Supports recruitment strategy and activities when targets are not met (e.g. utilization of PR&R; materials, booster visits, phone contacts).
- Interacts closely with local CRO team throughout the lifecycle of the study.
- Helps coordinate and/or attends the SSE booster visit requested by SSE-PL/SSE-SL.
- Regularly interacts with priority sites in assigned trials.
- Helps to maintain study specific trackers (booster visits) as needed or requested.

EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal chance employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.

📌 Sr. Manager Study Site Engagement Lead (Toronto)
🏢 LanceSoft
📍 Toronto