Associate Director, Clinical programming

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: Associate Director, Clinical Programming

Function/Department: Development Operations, Data Management

Reports to: Director, Data Management

FLSA Category (US ONLY): Exempt

Job Description

Position Summary:

The Associate Director, Clinical Programming (AD-CP) will serve as a key member of the Development Operations, Data Management team. The AD-CP will lead Clinical Programming activities, as well as contribute to process improvement activities, business development, cross functional training, and positive customer experiences. They are also responsible for project timelines and financial results. The AD-CP will assist with partnership/vendor relationship management and oversight activities while guiding the Clinical Programming team to ensure strategic alignment with overall company objectives.

Accountabilities:

Position Responsibilities/

• Develop and implement resourcing strategies to ensure all Clinical Programming projects are completed in a quality manner on time and within budget. This includes evaluating the quality and competency of all Clinical Programming resources (inclusive of internal and externally contracted) that are 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.
• Explore and/or implement efficiency measures to reduce development time on EDC build efforts and data delivery programming (i.e., programming SAS edits, data cleaning, coding, and laboratory reports).
• In partnership with Quality Management, provide leadership to develop and implement Clinical Programming processes and ensure that processes and systems are aligned with corporate strategy and objectives.
• Identify activities outside the scope of contracted work, prepare cost estimates and follow scope issues through to resolution.
• Provide support to business development efforts, as necessary (i.e., Sponsor Meetings, capabilities presentations, bid defenses, conference attendance). Attend capabilities presentations, as necessary.
• 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.
• Represent Clinical Programming on project teams either in person or through their direct reports assigned to project.
• Provide hands-on programming support, as needed or assigned, for eCRF development, edit check, listing, reporting and data displays.
• Advise clients on best practices for clinical database builds, eCRF layout, and compliance with CDISC standards.
• Manage scheduling and time constraints across multiple projects and multiple locations communicating timelines via MS project or other tool input.
• Conduct a post-trial analysis to identify efficiency opportunities that can improve overall data accuracy as recommendations to Management for consideration.
• Work collaboratively with other functional leaders in the design of new and enhanced biometric tools.
• Ensure that all staff continually maintain the established training requirements for the defined Clinical Programming team according to Catalyst SOPs, Job Aids, and templates.
• Responsible for the management of external vendors providing programming services.
• Participate in the interviewing and hiring process of Biometrics candidates as required for projects according to client needs.
• Responsible for administrative management of assigned staff (approve/track time-off requests, review timesheets/expense reports, ensure staff is compliant with required trainings, etc.).
  
  

Managerial Requirements/ Responsibilities:

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

Position Qualification Requirements:

Education: 4-year computer science/math degree or equivalent required; master's degree preferred.

Experience:

• A minimum of 10 years of relevant work experience, including experience with Clinical Database Management Systems (e.g., Medidata Rave, Medrio, IBM CD); SAS experience a plus.
• 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:

• Experience managing staff and teams using a collaborative approach.
• Ability to train and mentor staff.
• Excellent organizational, interpersonal, and oral/written communication skills are required.
• Extensive knowledge of clinical trial study design.
• Experience with clinical database management / electronic data capture systems (Medidata or Medrio knowledge preferred).
• Ability to prioritize, multi-task, and work as part of a team.
• Ability to be discrete with sensitive company information.
• 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.
• Travel for meetings and/or training activities may be required.
  
  

Physical Demands (US ONLY):

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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Skills Required
Coding, cdisc standards , Sas, Data Cleaning, Microsoft Office Suite