Clinical Data Manager II

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 to join our team! As a Clinical Data Manager II, 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

• Provides DM functional support to help deliver quality and timely data in a manner that enhances the integrity, speed, and outcomes of the trial.
• Interfaces with the project team and sponsors across the lifecycle of the project to proactively ensure data integrity and quality.
• Mentors more junior DMs and other project team members on areas related to data management.
• Works closely with lead DMs and other lead project team members to ensure project execution and sponsor satisfaction.
• Effectively aides in presentation of information and response to questions from sponsors, senior managers, project team members, and clinical trial sites.
• Ensures compliance with standard operating procedures.
• Aides in design of eCRF and reviews with lead DM and study team to ensure design is robust and minimizes risk. Works particularly closely with the lead DM and statistician to translate study outcomes, protocol guidelines and prior build experience into eCRF design.
• Helps in creation and implementation of data management plans (DMPs), data entry guidelines, data completion guidelines and other study documents.
• Along with lead DM, manages 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.).
• Defines clinical database variables (type, format, univariate validation checks) from an annotated CRF using either DMS or EDC data dictionaries.
• Assists in reviewing and approving 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. Ability to write simple edit checks using SAS or similar languages is required.
• Reviews recommended data management tools and selects the best tools for the study, leveraging study metadata and automation to minimize manual error and facilitate deeper understanding of study data.
• Uses data cleaning tools to identify data trends and potential issues early in the study, and implements intervention plans with project team to address issues.
• Holds periodic multidisciplinary data reviews with the project team to review data trends and anomalies, and to proactively address risks.
• Follows-up with the project team to answer questions, to ensure data timeliness and cleanliness, and to process and follow queries to closure.
• Aides in conduct or oversight of completion of all activities for database lock, ensuring data integrity and adherence to applicable regulations.
• Ensures all study materials are finalized in an eTMF and archived for delivery.
  
  

Qualifications

• BA/BS degree along with 2+ years of experience in developing clinical trials databases in a commercially available EDC system (i.e. RAVE, Medrio, Phase Forward, Oracle Clinical)
• 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 customizing and using various tools for data base build and data cleaning.
• Demonstrated programming skills, with experience in SAS, R or Business Objects IX as a plus.
• Experience importing/cleaning external data transfers a plus.
• Excellent verbal and written communication and interpersonal skills.
• Must be a self-starter, able to work independently and have the ability to coordinate multiple activities simultaneously in support of various projects
  
  

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 $75,000-95,000 per year.

EOE. Veterans/Disabled

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