Manager, Data Management

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

Position Title: Manager, Data Management

Function/Department: Clinical Development Operations, Data Management

Reports to: Director, Data Management

FLSA Category: Exempt

Job Description

Position Summary:

The Manager, Data Management will serve as a key member of the Leadership Team, supporting the strategic direction for the data management discipline, and ensuringe that appropriate techniques are used which guarantee the validity, accuracy, and overall quality of clinical trial data. The Manager, Data Management will lead all data management and clinical coding activities as well as, contribute to process improvement activities and positive customer experiences. They are also responsible for CDM project timelines and financial results.

Accountabilities

Position Responsibilities/

• Develop and implement resourcing strategies to ensure all CDM projects are completed in a quality manner on time and within budget. This includes evaluating the quality and competency of all CDM resources that are to be used on projects.
• Provide strategic leadership to develop and implement CDM processes and ensure that processes and systems are aligned with corporate strategy and objectives.
• Identifies CDM activities outside the scope of contracted work, prepares cost analysis documentation and follows scope issues through to resolution.
• Represents data management on project teams. Manages scheduling and time constraints across multiple projects and multiple locations.
• Keeps Sponsor and team members aware of project issues.
• Tracks timelines in relation to work completed and keeps CDM management, sponsor and the project team appraised of progress towards milestones.
• Maintains a consistent, manageable workflow for CDM project team by monitoring enrolment information and communicating with project team to actively influence data collection.
• Conducts an analysis after study completion to determine positive and negative factors affecting the project and provides this information along with study metrics to CDM management.
• Participates at bid defense meetings and sponsor presentations.
• Accurately estimates hours needed to complete CDM activities and proactively keeps Project Leader and CDM management informed of resource needs and under/over utilization.
• Keep management abreast of issues and progress on all assigned projects.
• Provides or arranges for project specific training for CDM team members.
• Monitors quality of work performed by CDM project team; coaches staff where necessary.
  
  

Supervisory Requirements/ Responsibilities

Position will have management responsibilities. Development, oversight, & direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, performance appraisals, goal setting, & salary review.

Position Qualification Requirements

Education & Experience:

• Bachelor’s degree in related discipline and 10 years of related experience; or,
• High School diploma and six to eight years of related experience, or;
• Equivalent combination of education and experience
  
  

Required Certifications

NA

Required Skills

• Proficient with Microsoft Office Suite.
• Excellent written and oral communication skills.
• Excellent presentation skills.
• Strong organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills.
• Ability to deal effectively with a diversity of individuals at all organizational levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Ability to work independently and as a member of various teams and committees.
• Good judgement with the ability to make timely and sound decisions.
  
  

Physical Demands

Sedentary work that primarily involves sitting/standing

Acknowledgement

My signature below acknowledges that I have read the above job description and agree that I can perform the responsibilities and meet the requirements as presented. I understand this job description provides a general outline of job responsibilities and requirements and is not intended to be all-inclusive. I also understand that job responsibilities and requirements may change at any given time based on organizational or departmental needs.

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