Clinical Data Manager II / Sr. Clinical Data Manager

Overview

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

We are currently hiring a Clinical Data Manager II or Senior Clinical Data Manager to join our team! You'll have the opportunity to work closely with the multidisciplinary project team across the life cycle of the study to ensure data management is thoughtfully planned and delivered in a consistent, timely, and high quality manner. You will be a key contributor to project success through development and utilization of innovative tools to help automate manual tasks and identify data trends in a timely fashion and constant collaboration with project peers, particularly biostatisticians, statistical programmers, and clinical operations personnel. You will also independently perform data management tasks to ensure clinical database design supports study outcomes; proactively clean clinical trial data and mitigate risks; effectively communicate data-related decisions to sponsors; and ensure data management activities follow all applicable standards and study-specific procedures.

Our Data Management will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

Responsibilities

• Provide DM functional support and/or leadership to help deliver quality and timely data in a manner that enhances the integrity, speed, and outcomes of the trial.
• Interface with the other DMs, project team, and sponsors across the lifecycle of the project to proactively ensure project execution, data integrity and quality and sponsor satisfaction. Follow-up with the project team to answer questions, to ensure data timeliness and cleanliness, and to process and follow queries to closure.
• Mentor more junior DMs and other project team members on areas related to data management.
• Effectively aide in presentation of information and response to questions from sponsors, senior managers, project team members, and clinical trial sites.
• Ensure compliance with standard operating procedures.
• Aid in design of eCRF and review with other lead DMs and study team to ensure design is robust and minimizes risk. Work particularly closely with other lead DMs and statistician to translate study outcomes, protocol guidelines and prior build experience into eCRF design.
• Help in creation and implementation of data management plans (DMPs), data entry guidelines, data completion guidelines and other study documents.
• Manage electronic data capture (EDC) system design, development, testing, and validation, including oversight of all database specifications (eCRF, SDTM where applicable, edit check, external transfer, randomization, etc.).
• Define clinical database variables (type, format, univariate validation checks) from an annotated CRF using either DMS or EDC data dictionaries.
• Review and approve creation of all edit checks, including validation of simple univariate and multivariate edit checks, programming of complex multivariate validation checks, and UAT of system edit checks with your ability to write simple edit checks using SAS or similar languages.
• Review recommended data management tools and select the best tools for the study, leveraging study metadata and automation to minimize manual error and facilitate deeper understanding of study data.
• Use data cleaning tools to identify data trends and potential issues early in the study, and implement intervention plans with project team to address issues.
• Hold periodic multidisciplinary data reviews with the project team to review data trends and anomalies, and to proactively address risks.
• Aid in conduct or oversight of completion of all activities for database lock, ensuring data integrity and adherence to applicable regulations.
• Ensure all study materials are finalized in an eTMF and archived for delivery.

Qualifications

• BA/BS degree along with at least 5 years of clinical data management experience which includes 1-2 years in a DM lead role and 1-2 years of experience in developing clinical trials databases in a commercially avai