Manager, Clinical Data Management - Remote

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.

VACCINATION REQUIREMENT:

To be considered for U.S. based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.

EDUCATION REQUIREMENTS:

Bachelor's degree in social sciences. Degree in information systems or related field with experience

in social sciences is preferred.

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS: N/A

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: 0% - 5%

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.