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Manager, Clinical Data Management - United States  

Bio Clinica (company)


Posted on : 26 April 2017

Project Description

Job Description 
  • Our company is looking for intelligent, creative and dedicated professionals to join our growing team. 
  • We are a company that values technical excellence, teamwork and a commitment to success. 
  • We employ cutting edge technology to provide our customers with industry leading solutions and are currently seeking to fill the position of Manager, Clinical Data Management.

Primary Responsibilities 
Responsible for the direction and management of all internal data management activities by:  
  • Direct supervision of staff including Clinical Data Managers and/or Clinical Data Reviewers. 
  • Supporting Clinical Data Managers and/or Clinical Data Reviewers to ensure they have all the knowledge and tools necessary to perform their CDM/CDR duties. 
  • Overseeing and ensuring staff is providing adequate DM services to customers. 
  • Participating in the creation and modification of SOPs and WIs to support the DM department. 
  • Developing and implementing departmental process improvements as needed. 
  • Reviewing and providing feedback on all contracts that include Data management services to ensure DM pricing is reasonable. 
  • Attending and presenting at organizational meetings as required. 
  • Ensuring all project forecasts and projections are completed on time and with accuracy. 
  • Ensuring all project billing is completed on time and with accuracy.  

Performs supervisory functions by: 
  • Coaching staff to assure compliance to customer and internal requirements, specifically data management processes and procedures, for assigned projects. 
  • Assures equal distribution of work across each Clinical Data Manager/Reviewer 
  • Conducting performance reviews for all direct reports 
  • Coaching, counseling and disciplining direct reports 
  • Initiating, coordinating and enforcing systems, policies and procedures. 
  • Conducting new hire interviews.  

Ensures client satisfaction by: 
  • Working with sales and marketing to promote data management services and expand the service offering.  

Maintains quality service and departmental standards by: 
  • Adhering to CDM processes and standards by using implemented systems. 
  • Assisting in the defining/redefining of existing processes for data management. 
  • Mentoring and training new employees. 
  • Developing, reading, understanding and adhering to organizational Standard Operating Procedures (SOPs).  

Working conditions: 
  • Travel: 0-25% 
  • Lifting: 0-20 lbs 
  • Other: Computer work for long periods of time  

Required Skills 
  • Bachelor’s degree preferred  

Additional skill set: 
  • Strong interpersonal and communication skills, both verbal and written 
  • Strong organizational and leadership skills 
  • Goal oriented 
  • Ability to promote and maintain a positive and professional and positive attitude 
  • Fluency in English (both verbal and written) is required   

Required Experience 
  • Experience as a Lead Data Manager within a CRO or pharmaceutical environment or other relevant positions utilizing a project and/or data management skillset is required. 
  • 7+ years working in an Electronic Data Capture environment. 
  • 7+ years of data management or experience working with clinical trials and/or within pharmaceutical or clinical environment 
  • Understanding of clinical trial terminology. 
  • Proven ability in analyzing data. 
  • Experience working with computer software including MS Office.