Manager, Clinical Data Management
- Experience Level
- Experienced (non-manager)
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
A Manager, Clinical Data Management (Manager, CDM) is responsible for managing data review activities and staff to ensure all time frames and targets are met across the department.
- Managerial Responsibilities
- Onboarding of new employees including training on data management procedures and systems.
- Mentor, monitor, and supervise direct reports (including monitoring time reporting and training requirements).
- Conduct performance reviews and assist with goal setting of direct reports.
- Assist with resourcing assignments for Clinical Data Managers.
- Act as the Clinical Data Manager or Project Data Manager for assigned projects.
- May be responsible or project budget oversight, revenue recognition and forecasting, billing, invoking, and generation of change orders.
- Identify data management project issues and work with Senior Department Management on remedial action.
- Assist in the creation and documentation of a new or revised departmental procedures and guidelines.
- Create materials for and represent Clinical Data Management at Business Development related meetings.
- Assist in the creation of Business Development proposals by supplying data management related information and costs.
- Represent Advanced Clinical at professional meetings.
- Participate in the recruitment and selection of Data Management personnel.
- Perform other duties as requested by management.
A Bachelor's Degree and at least 8 years of experience in data management and/or management approval/recommendation is required. Five years of progressively responsible clinical or data management experience, preferably including project management and staff supervision, with three years of data management experience. The candidate must have strong project management skills, excellent verbal and written communication skills, the ability to serve in a leadership role including effective mentoring skills and the ability to deal effectively with sponsors and internal customers. The candidate must be willing to take on additional projects, work overtime when necessary, and travel on occasion.
Minimum Training Requirements
The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:
- Applicable Standard Operating Procedures
- Good Clinical Practices (GCP Regulations' ICH Guidelines; Good Quality Practices)
- 21 CFR Par 11 and Computer Security (Part 11, Electronic Records; Electron Signature-Scope and Applications; 21 CFR 11 and Industry Guidance's; Computerized Systems Used in Clinical Trials)
- Good Clinical Data Management Practices
- Drug Development and Approval Process
- Data Management Overview
- MedDRA and WHODRUG Overview
- Sponsor/Study specific trainings, when applicable
- Applicable system training
What's in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:
Our Culture: https://careers.advancedgroup.com/embrace-our-culture
Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential
Community Programs: https://careers.advancedgroup.com/unleash-your-passion
For a complete list of all of our job openings, please visit Advanced Group's career site here .
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This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.