General Information

Location: Princeton, NJ, Remote

Organization: Medavante-Prophase, Inc

Job Type: Full Time - Regular

Description and Requirements

ABOUT WCG: WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring the risks of progress never outweigh the value of human life.


WHY WE LOVE WCG: At WCG, our employees are our most valuable asset, and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health to help make the most of their future.

  • Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
  • Employee Assistance Programs and additional work/life resources
  • Referral Bonuses and Tuition Reimbursement
  • Flexible PTO
  • Volunteer Time Off to benefit the community
  • Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement

Expected annual base salary range: $69,840 to $108,500

GPS level: M1

JOB SUMMARY: The Manager Clinical Data Management will be responsible for managing a Clinical Data Management (CDM) team and initiating and coordinating Clinical Data Management activities for clinical studies, representing Data Management as the primary point of contact with clients and internal members of the study team.

EDUCATION REQUIREMENTS: Bachelor’s degree in social sciences. Degree in information systems or related field with experience in social sciences is preferred.

QUALIFICATIONS/EXPERIENCE: The requirements listed below are representative of the knowledge, skills, and/or ability required.

  • At least three years of experience in managing data, including data entry, data collection and transfers. Previous work on multi-center clinical trials is ideal.
  • Knowledge of document management processes and software (Microsoft Excel, SPSS, SAS, MathLab or R).
  • Strong working knowledge of data management processes and applicable global regulatory requirements.
  • Knowledge of how to create, implement and maintain data file structures.
  • Knowledge of ICH GCP as it applies to data management and statistical analysis.
  • Basic understanding of clinical development and data management processes.
  • Demonstrated ability to prioritize multiple projects and deliverables.
  • High attention to detail, ability to multi-task and be collaborative.
  • Strong computer skills with demonstrated experience in Microsoft Office Software.
  • Excellent written and oral and written communication/presentation skills in English.
  • Understanding of clinical medical concepts and terminology.
  • Knowledge of Guidelines for GCP, 21 CFR Part 11 regulations, and Regulatory requirements for clinical studies.

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. Serve as Clinical Data Management leader on all assigned projects and activities, maintains quality service by enforcing quality and customer service standards, analyzing, and resolving quality and customer service problems, identifying trends, and recommending system improvements.

  • Primary CDS Contact for all study start up activities, setting up data delivery and transfer systems, identifying and implementing study processes as the study protocol and sponsor requires, identifying needs of the study, working in conjunction with CDM management to assign personnel and roles.
  • Implements data management procedures necessitated by protocol and Scope of Work, produces Clinical Data Science Plans (CDS Plans), Data Management Guidelines, and other internal training documents for each new study, versioning documents as changes are necessary. Monitors and maintain the databases and restructures if needed, including confirming the validity of the data contained in the file databases.
  • Ensures database maintenance and quality control by collaborating with the Senior Statistician.
  • Defines database design and management standards and document new and existing systems and procedures.
  • Assists in the implementation of operating methods and preparation of cumulative study-specific files and uploads to improve processing, distribution, data flow, collection and database editing procedures.
  • Troubleshoots problems concerning database records and communicate this information to sites (and Sponsors, if necessary).
  • Sets Data Management schedules in conjunction with the Senior Statistician and Project Managers.
  • Advises Clinical Operations and Clinical Services teams in execution of study protocol through coordination of deliverable and non-deliverable documentation schedules.
  • Contributes to design of eCOA scales for use, researching scale rules, appropriate administration, and item relationships to develop data monitoring algorithms.
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
  • Maintain a thorough understanding of regulatory requirements for clinical trials.
  • Proactively identify and implement opportunities for process improvements.
  • Represents Clinical Data Management department at client meetings.
  • Develops and maintains relationships with key sponsor personnel.

SUPERVISORY RESPONSIBILITIES: The position will require the individual to be responsible for the management, direction, coordination, performance, and evaluation of an assigned team and staff. Responsibilities may include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

 

TRAVEL REQUIREMENTS: This role may require up to 5% travel which may be domestic or international, including overnight and weekend stays, consistent with project needs and office location.

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to perform sedentary work which includes sitting for long periods of time and occasionally required to lift 25lbs (11.3 kg). Further guidance on physical activities, requirements, visual acuity, and working conditions is available in HCM.


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