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Senior Manager, Clinical Data Management (Remote / Home Based)


This is a Contract position in Morrisville, NC posted June 12, 2019.

Back to Search ResultsSenior Manager, Clinical Data Management (Remote / Home Based)Clinipace is a global full-service clinical research organization (CRO) serving the unique needs of venture-backed, mid-tier and strategic pharmaceutical, biotechnology and medical device firms.

We help our customers advance drug candidates to deliver successful stakeholder and patient outcomes.

We leverage extensive therapeutic knowledge, clinical trial expertise, and comprehensive innovative technology to support life science firms in achieving some of their most important goals: Executing regulatory strategies, optimizing clinical development timelines and completing high quality trials.

We are proud to have a culture that is vibrant, supportive, performance-driven, and passionate while focusing on continual learning and development.

Clinipace associates are passionate about their lives and bring that same passion to their work at Clinipace.

Work Location: United States | North Carolina (Morrisville) Job Code: 4193DescriptionJob Title: Senior Manager, Clinical Data ManagementLocation: United States (Regional, Home based)Job Overview: 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 Worldwide 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 neededConduct internal and external team meetings as necessary.Proactively identify and address problems.

Seek to understand all contributing factors.

Propose, implement, and evaluate appropriate solutions.Supervisory Responsibilities:This job involves supervisory responsibilities for other employees or contractors, which may include:Clinical Data Manager (I, II or Senior)Job Requirements:EducationCollege graduate with a life science, computing or nursing qualifications preferred.

ExperienceMinimum 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 preferredPrior trial responsibility for entire data management life-cycleWorking knowledge of EDC studiesExperience working in a home office environment, as applicableSkills/CompetenciesExcellent organizational skillsStrong written and verbal communication skillsExceptional attention to detailKnowledge of clinical research including regulatory requirements GCP/ICHStrong interpersonal skills; serve as the primary company liaison for data management issuesStrong computer skills, including Microsoft Office and clinical data management systemsAble to exercise judgment within defined procedures and practices and to determine appropriate action independentlyDecision making, planning and delegation skillsMature management skills demonstrated by calm and thorough review of situations.CapabilitiesFlexibility
– willing to change assignments and work focus to accommodate project demandsTeam player – effective proactive participant as a team member and team leader.Dedicated home office environment for field based employees, as applicable.LI-JM1The company will not accept unsolicited resumes from third party vendors.Are you a returning applicant?Previous Applicants:Email:Password: If you do not remember your password click here.New Search