Senior 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.

As our next Senior Clinical Data Manager, you will 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 and oversee completion of 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 Clinical Data Managers 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 leadership to deliver quality and timely data in a manner that enhances the integrity, speed, and outcomes of the trial.
• Interface with the project team and sponsors across the lifecycle of the project to proactively ensure data integrity and quality;
• effectively present information and respond to questions from sponsors, senior managers, project team members, and clinical trial sites;
• hold periodic multidisciplinary data reviews with the project team to review data trends and anomalies, and to proactively address risks;

follow-up with the project team to answer questions, to ensure data timeliness and cleanliness, and to process and follow queries to closure.

• Mentor junior DMs and other project team members on areas related to data management; train site personnel on EDC system, eCRF, and additional tools such as ePRO when needed.
• Make strategic decisions and recommendations related to the data that benefit the project.
• Ensure compliance with standard operating procedures.
• Manage database design, development, testing and system validation for new studies.
• Lead design of eCRF and review with study team to ensure design is robust and minimizes risk; work particularly closely with the lead statistician to translate study outcomes, protocol guidelines and prior build experience into eCRF design;

lead electronic data capture (EDC) system design and validation, including oversight of all database specifications (eCRF design, edit checks, external data transfers, IWRS integration, etc.).

• Create and implement data management plans (DMPs), data validation plans (DVPs), and other study documents; ensure that the project team is trained and has a shared understanding of how data will be cleaned and each person’s role in the process.
• Review and approve creation of edit checks, including validation of simple univariate and multivariate edit checks, programming of complex multivariate validation checks, and UAT of system edit checks.
• Create and maintain data transfer agreements with external vendors and leads external data cleaning activities.
• 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 issue, review, and close queries and to identify data trends and potential issues early in the study, and implement intervention plans with project team to address issues.
• Conduct or oversee 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 available EDC system (e.

g. RAVE, Medrio, RedCap, Veeva); Medidata RAVE build certification 5.6.4 a plus.

• Strong analytical skills with a demonstrated ability to identify trends in data and use insights to manage risks and drive decisions;
• strong technical acumen, with experience selecting, customizing, and using various tools for data base build and data cleaning;

demonstrated programming skills, particularly experience in SAS or Business Objects IX, is a plus.

• Strong Communicator : Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.
• Committed to Quality : Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
• High-Character : Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust.

We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.

Critical Thinker : Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience.

We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.

Agile and Adaptable : Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment.

We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.

A few more things to know about us :

Benefits : Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k).

All employees are eligible for paid time off, holidays, parental leave and bereavement leave.

Diversity and Inclusion : As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day.

By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world.

Flexibility : We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role.

Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience.

The range of starting pay for this role is $95,000 to $135,000 per year.

EOE. Veterans / Disabled

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