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Associate Director/Director, Clinical Programming
Catalyst Clinical Research is a niche provider of clinical research services through two established solutions- Catalyst Flex and Catalyst Oncology. Here at Catalyst Clinical Research we provide support and services exclusively to biotech companies because we know and understand the biotech environment. Our 15+ years of experience allow us to quickly grasp the evolving needs of our clients so we can deliver the solutions essential to meet the evolving needs and unexpected changes inherent in oncology development. When protocols amend or emerging data suggest a breakthrough straight from Phase I to registration, we are ready.
Position Summary: As an Associate Director/Director, Clinical Programming (AD/D-CP) you will serve as a key member of the Development Operations, Data Management team. You will lead Clinical Programming activities, as well as contribute to process improvement activities, business development, cross functional training, and positive customer experiences. You will also be responsible for project timelines and financial results. You will assist with partnership/vendor relationship management and oversight activities while guiding the Clinical Programming team to ensure strategic alignment with overall company objectives.
- 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.).
Position Qualifications and Requirements:
- 4-year computer science/math degree or equivalent required; Master’s degree preferred.
- 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.
- 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.
- 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.
- 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.
Catalyst Clinical Research, LLC is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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