Experien Group | Now a Part of Veranex
Website:
veranex.com
Job details:
Veranex’s mission as an
Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’
Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.
About This Role:
Veranex has an exciting opportunity to join our team as Manager, Clinical Database Programming. You will be part of a team working to improve lives globally through medical technology innovation. The Manager, Clinical Database Programming will be responsible for overseeing the utilization of primary data management development tools to program, test, and maintain databases to meet specifications according to company and/or client standard operating procedures. Collects, interprets, and analyzes customer feedback. Accesses billability to determine areas of inefficiency and/or highlight under-resourcing. Provides functional management to direct reports, including training, performance management, professional development, and coaching. Collaborates with functional management teams across the organization on project deliverables and timelines.
What You Will Do:
- Ensures high quality deliverables by providing senior review of study level/program level/multi-study core deliverables for accuracy. Assists with internal audits and attends sponsor audits.
- Participates in risk-based monitoring model and the Randomization and Trial Supply Management (RTSM) configuration and testing.
- Provides advanced technical expertise and support to the clinical database programming and data management teams.
- Provides leadership, training, guidance, and support to other programmers.
- Manages and leads projects and programming team on single or multiple projects. Manages programming and resourcing requirements to meet timelines.
- Participates in business development activities. Attends project and departmental review meetings.
- Manages the budget of assigned projects throughout the life cycle.
- Performs resource management activities in ERP tools.
Qualifications:
Required skills:
- Bachelor’s degree and 6 - 8 years of relevant work experience, including 2+ years of direct people management experience.
- Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
- Provides guidance to employees within the latitude of established company policies.
- Recommends changes to policies and establishes procedures that affect immediate organization(s).
- Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors. Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
- Provides guidance to employees to meet schedules and/or resolve technical problems. Develops and administers schedules and performance requirements. May have budget responsibilities.
- Manages the activities of a team of professional-level individual contributors with responsibility for results, including costs, methods and staffing.
Preferred:
- Good understanding of ICH guidelines, CDASH, CDISC, and relevant regulatory requirements.
- Good knowledge of company people management policies and procedures, including hiring, performance management, corrective action, and compensation administration.
- Good people management and mentoring skills including coaching, interviewing, and providing feedback and recognition.
- Strong interpersonal skills.
- Excellent oral and written communication skills.
- Strong quality-oriented analytical skills.
- Excellent attention to detail.
- Strong ability to effectively manage multiple tasks and projects.
- Ability to communicate complex business concepts to a multi-disciplinary audience.
- Ability to manage team resources to ensure attainment of departmental objectives.
- Hands-on experience with Medrio, MedNet, Viedoc, Medidata Rave, or equivalent EDC platforms.
- Experience designing, configuring, testing, and deploying clinical databases and edit checks.
- Working knowledge of Medidata Rave modules: Custom Functions, RTSM (Randomization and Trial Supply Management), TSDV (Targeted Source Data Verification), eCOA/ePRO solutions
- Experience with external data integrations, RTSM/IWRS, and eClinical technologies.
- Strong knowledge of database design, edit checks, UAT, release, and lock processes.
- Strong leadership, stakeholder management, communication, and problem-solving skills.
Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics. Applicants must be currently authorized to work in the United States on a full-time basis. The company is not able to sponsor visas or provide employment-based immigration sponsorship for this role now or in the future.
Protecting Your Job Search (Recruitment Scam Awareness)
At Veranex, we believe our people are what set us apart, and our commitment to supporting talent begins the moment you consider joining our team. We aim to provide every candidate with a safe and transparent recruiting experience. As phishing and recruitment scams continue to target job seekers worldwide, here are a few items to keep in mind:
- Official communications will only come from company email addresses ending in @veranex.com.
- We will never ask you to send money or provide banking information at any stage of the recruitment process.
- Be cautious of unexpected emails and avoid opening suspicious links or attachments.
- When in doubt, contact us. If you have questions about the authenticity of a communication you've received, please contact our recruiting team at careers@veranex.com before responding
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