Job Title: Senior Manager, Clinical Data Management
Job Location: US - Remote/Home Based
The Senior Manager, Clinical Data Management is responsible for the coordination of data management activities and staff performing these activities which include processing of case report form and electronic data in accordance with Clinipace SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.
Job Duties and Responsibilities:
The specific job duties of a Senior Manager, include those of Senior Clinical Data Manager, Clinical Data Manager II and Clinical Data Manager I and may include but are not limited to:
Personnel Management - Line management including appraisals, training and mentoring of team members in accordance with established departmental procedures.
Provide management and oversight of all Data Management activities.
Active involvement in departmental and organisational meetings and initiatives.
Develop and document departmental procedures.
Participate in the review of cross functional department procedures.
Participate in reviewing and responding to QA audit reports.
Support of business development meetings as needed
Conduct internal and external team meetings as necessary.
Proactively identify and address problems. Seek to understand all contributing factors. Propose, implement, and evaluate appropriate solutions.
This job involves supervisory responsibilities for other employees or contractors, which may include:
College graduate with a life science, computing or nursing qualifications preferred.
Minimum of 7 years of experience and/or demonstrated aptitude for data management work and managerial skills.
International team experience preferred.
Experience working in pharmaceutical and/or Contract Research Organization (CRO) industry preferred
Prior trial responsibility for entire data management life-cycle
Working knowledge of EDC studies
Experience working in a home office environment, as applicable
Excellent organizational skills
Strong written and verbal communication skills
Exceptional attention to detail
Knowledge of clinical research including regulatory requirements GCP/ICH
Strong interpersonal skills; serve as the primary company liaison for data management issues
Strong computer skills, including Microsoft Office and clinical data management systems
Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
Decision making, planning and delegation skills
Mature management skills demonstrated by calm and thorough review of situations.
Flexibility - willing to change assignments and work focus to accommodate project demands
Team player effective proactive participant as a team member and team leader.
Dedicated home office environment for field based employees, as applicable.
Clinipace is an Equal Opportunity Employer and provides fair and equal employment opportunity to all employees and applicants regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State, or local laws. All employment decisions are based on valid job-related requirements.
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The company will not accept unsolicited resumes from third party vendors.