Job Description

Position Summary:

The Associate Director of Data Management is a key member of the Clinical Development Operations, Data Management Team. The AD of Data Management will provide daily supervision of Data Management, Coding and personnel. Act as company lead for client and regulatory audits and maintain SOPs.

Position Responsibilities/

Accountabilities:

• Assist in Developing, leading, and oversight of data management department.
• Provide input for the financial responsibility for the data management department.
• Act as departmental representative for Quality Assurance activities.
• Work cross-functionally to set strategy for data management function.
• Develop and track metrics on productivity and quality and create strategies and best practices.
• Hire, supervise, and mentor reporting staff in tasks and activities in order to develop the team structure and enhance departmental and project performance.
• Assist in developing and implementing resourcing strategies to ensure all data management projects are completed in a quality manner on time and within budget.  This includes evaluating the quality and competency of DM resources (internal and externally contracted) to be used on projects.

·         Provide clear direction to direct reports while holding them accountable for work product quality, cross functional communications, and overall accuracy of client deliverables.

·         Maintain an awareness of project issues and support teams as needed to maintain a positive relationship with clients. Act as a point of escalation as needed.

• In partnership with Quality Management, provide strategic leadership to develop and implement data management processes and ensure that processes and systems are aligned with corporate strategy and objectives.

·         Assist in strategic business development and provide input to proposals as necessary (i.e., Sponsor Meetings, capabilities presentations, bid defenses, conference attendance). Attend capabilities presentations, as necessary.

·         Conduct a post-trial analysis to identify efficiency opportunities that can improve overall data accuracy as recommendations to Management for consideration.

·         Work with the Project Leaders and Biometrics management regarding resource needs and under/over utilization.

·         Ensure that all staff continually maintain the established training requirements for the defined data management team according to Catalyst SOPs, Job Aids, and templates.

·         Approve and track PTO requests for direct reports to ensure coverage during peak times.

·         Review timesheets/expense reports/invoicing for utilization and payment.

·         Review and approve non-billable travel requests for the data management team.

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.

Position Qualification Requirements:

Education: Master’s degree, equivalent, or higher in science, mathematics, or a related field.

Experience: A minimum of 12 years of relevant work experience.

Note:  A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above.

Required Certifications: N/A

Required Skills:

• Excellent verbal, written, and interpersonal skills.
• Experience managing staff and teams using a collaborative approach.
• Ability to train and mentor staff.
• Extensive knowledge of clinical trial study design.
• Experience with clinical database management/electronic data capture systems (EDC systems with Medidata knowledge preferred).
• Able to work independently on multiple, concurrent projects.
• Can attend study team meetings as needed.

·         Previous experience in a pharmaceutical research or CRO setting required/preferred.

·         Proficient with Microsoft Office Suite.

·         Strong organizational, problem-solving, and analytical skills.

·         Versatility, flexibility, and a willingness to work within constantly changing priorities.

·         Ability to deal effectively with a diversity of individuals at all organizational levels.

·         Commitment to excellence and high standards.

·         Good judgement with the ability to make timely and sound decisions.

·         Ability to be discrete with sensitive company information.

·         Ability to travel frequently for meetings and training activities may be required.

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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