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.
What We Do
Dianthus is a biotechnology company dedicated to designing and delivering the next generation of best-in-class monoclonal antibodies with improved selectivity and potency. Led by a multidisciplinary team of seasoned biotech entrepreneurs and scientists, we are pioneering selective antibodies of validated and emerging complement targets to allow people with rare and severe autoimmune diseases live healthier lives to their fullest potential.
