About Us

About the Role

The Senior Manager / Associate Director, Centralized Monitoring will play a critical role in ensuring the integrity, accuracy, and completeness of clinical trial data.

You will support bringing the central data review process in-house from the CRO, oversee data review activities across multiple studies, work closely with CRO Clinical Study Teams, and internal cross-functional teams to ensure high-quality data that supports regulatory submissions and scientific publications. You must have extensive experience as a CRA and ideally a healthcare background in order to be successful in this role.

This is an exciting opportunity to be a part of a high profile team building our internal data review processes to ensure alignment across the development teams. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Lead and manage clinical data review activities across assigned studies.
• Actively participate in data review and protocol deviation review meetings.
• Collaborate with CROs to oversee data cleaning, query resolution, and database lock processes.
• Review clinical data, data listings, and reports to identify inconsistencies, trends, and potential issues.
• Identify, assess, and escalate data anomalies and protocol deviations.
• Partner with Clinical Development Operations, Clinical Development, Data Management, and Biostatistics to ensure data quality and compliance.
• Develop and implement data review plans and contribute to data management plans.
• Support Data Management activities (e.g., CRF design, User Acceptance Testing)
• Participate in CRO oversight, including performance monitoring and issue resolution.
• Support audit readiness and regulatory inspections by ensuring data traceability and documentation.
• Mentor junior team members and contribute to process improvement initiatives.

Experience

• Minimum of 5 years of experience in clinical research, including experience as a Sr. Clinical Research Associate (CRA), Lead CRA, or in a data oversight role. Registered Nurse (RN), or equivalent clinical/medical background (e.g., MD, PA, study coordinator) preferred.
• Strong understanding of clinical trial processes, GCP, and global regulatory requirements.
• Experience working with CROs and managing outsourced data review activities.
• Proficiency in reviewing EDC systems and clinical data listings. [Experience with targeted source data verification (tSDV) strongly preferred.]
• Excellent analytical, critical thinking, organizational, and communication skills.
• Experience with process improvement initiatives (e.g., process revision, plan development, SOP development, etc.)
• Ability to work independently in a fast-paced, startup environment.

About Us

About the Role

We are building our Clinical team and need two Senior Clinical Trail Associates who are open to owning end-to-end processes. You will report directly to the respective Senior Director, Clinical Development Operations global leads.

As the Senior Clinical Trial Associate (Sr. CTA)/ Sr. Associate, you will play a crucial role in the Clinical Development Operations (CDO) department to support the planning, execution, and management of clinical trials in accordance with regulatory requirements and industry best practices.  In this role, you will collaborate with cross functional study teams, clinical Research Organizations (CROs), and other external vendors to ensure the successful delivery of clinical study activities.

You must have experience supporting global clinical study teams in order to be successful. Experience in rare diseases is ideal, however not required. We are looking for someone who can grow with our organization and will continue to support your ongoing development. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Provides support to assigned clinical studies, taking on various responsibilities to support project and study deliverables.
• Coordinates, attends and may lead study team meetings; ensures appropriate meeting scheduling and documentation, including creation, distribution and filing of meeting agendas and minutes.
• Maintains and generates applicable study trackers and documents (for example: action-decision log, storyboard, patient enrollment and IRB approvals).
• Monitors clinical trial insurance and license agreements across studies and work with vendors to ensure current agreements.
• Supports the development and review of study documents, including study manuals.
• Maintains knowledge and acts as team super-user or subject matter expert for study-related systems and processes.
• Manages deliverables and navigates changing priorities.
• Supports the clinical team with coordination and preparation for investigator meetings, PI calls, conferences as well as internal clinical meetings.
• Supports management of the Trial Master File according to Sponsor Oversight plan to ensure accuracy and completeness.
• Assists with study budget oversight, including invoice tracking, reconciliation and collaboration with cross-functional teams and vendors.
• Participates in vendor selection and management meetings (e.g., CROs, IVRS, Central Labs, etc).

Experience

• BA/BS degree or equivalent, relevant work experience.
• Minimum of 5 years’ experience working on clinical studies in pharmaceutical, biotech, or CRO setting preferred. Prior CTA experience required.
• Excellent interpersonal and communication skills with ability to work collaboratively across functional teams.
• Strong organizational and time management skills, and strong attention to detail.
• Knowledge of global regulatory and compliance requirements for clinical research.
• Experience with essential documentation for Trial Master Files required.
• Knowledge of drug development, clinical operation processes, medical terminology, and procedures according to FDA GCP/ICH regulatory guidelines.
• Excellence with MS Office products Word, Excel, SharePoint, PowerPoint.
• Experience working with clinical trial systems (CTMS, IRT, EDC) preferred.