VP Monitoring and Site Engagement

Alira Health

1d•Hybrid

About The Position

The Vice President, Monitoring and Site Engagement is a key member of the Alira Health Clinical leadership team. In this role, the VP oversees the Directors of Clinical Monitoring in Europe and North America, ensuring operational excellence across all monitoring activities and the consistent delivery of high‑quality outcomes to sponsors while meeting expectations, timelines, and regulatory standards. The VP is also responsible for establishing and leading a new organizational unit dedicated to feasibility assessments and the development and management of a robust network of site partnerships, including oversight of site contracting processes. In addition, the position oversees the Director of Study Start-Up, providing strategic and operational leadership to the study start up group. Core responsibilities include interviewing, hiring, training, resource planning, performance evaluation, mentoring, and ensuring compliance across all assigned teams and activities.

Requirements

15 years of experience in the pharmaceutical / biotechnology / CRO industry
8 years of management experience
Experience in monitoring all phases of clinical trials required
Proven leadership skills
Strong organizational management skills
Excellent written and verbal communication skills to clearly and concisely present information
Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
Excellent ability to handle multiple tasks and many administrative details in a fast-paced and constantly changing environment
Ability to exercise sound judgment and make decisions independently
Excellent self-motivation skills
Thorough understanding of drug development process and regulatory aspects of clinical development including ICH Good Clinical Practices
Strong interpersonal skills, as well as the ability to function in a team environment
Proficient with MS Office Suite, particularly Word and Excel

Nice To Haves

Previous experience at a sponsor/pharmaceutical company preferred
Experience of providing client oversight/management

Responsibilities

Serves as a leader, point of mentorship, and point of escalation for the DirectorsDirectors of Clinical Monitoring, and Director(s) of Study Start Up.
Develops and maintains, together with the local Alira Health teams and local CRO partners as applicable, a network of existing and potential clinical study sites across all regions, and facilitates partnership with institutions to build a framework of collaboration.
Collaborates with sponsor and appropriate Alira Health team to facilitate negotiation/issue resolution for all issues around clinical monitoring, site engagement, site contracting, feasibility and participant recruitment.
Responsible for proactively identifying risks to quality and compliance, and developing mitigation plans to address.
Responsible for continual process improvement as related to clinical monitoring, site engagement and study start up, including developing and improving Standard Operating Procedures and other controlled documents.
Participates in sponsor and regulatory authority audits/inspections.
Accountable for clinical team performance indicators and metrics.
Oversees regular resource and workload assessments for the clinical monitoring team, feasibility team, study start up team, identifying areas where additional support is needed.
Meets regularly with direct reports, assists with their professional development and conducting annual reviews.
Responsible for selection and interviewing of potential employees, making hiring decisions.
Provides, together with the Directors of Clinical Monitoring, oversight and assessments of CRAs in consultation with the Lead CRA, including performing CRA evaluation/co-monitoring visits and leading corrective action plans, as appropriate.
Contributes to the creation of proposals and budgets for new projects.
Participates in BID Defense meetings and general capabilities presentations to potential new clients.
As an oversight project director role, assess the budget, risks and scope of projects and contracts undertaken together with the project leads and provide guidance and oversight as needed to ensure proper delivery.
In the same role, establish client expectations for delivery of relevant projects.
Oversee the management of external vendors to ensure that they are performing in accordance with contract specifications.
Complies with and ensures team compliance with ICH GCP guidelines, ISO14155, and company SOPs.