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Associate Director, Project Management

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Cary, United States Catalyst Clinical Research LLC Full time
Job DescriptionJob Description

As an Associate Director, Project Management you will be responsible for operational delivery of the studies and/or programs across the Project Management team. Associate Director, Project Management contributes towards development of the methodology for conduct of the clinical trials, improving current methodology, and being accountable for those assigned to them.

Position Responsibilities/Accountabilities:

  • Accountable for the activities of Project Management team members.
  • Provide strategic direction for project managers through direct line management of assigned staff; including onboarding training and provision of ongoing training as needed.
  • Evaluate and address employee performance through soliciting feedback from colleagues and clients.
  • Track staff utilization and gauge adequate resources and request additional staff from leadership as needed.
  • May be involved in interviewing and hiring process of clinical operations candidates as needed for successful project delivery.
  • May perform some or all PM responsibilities on key projects or as needed to support direct reports and/or clients.
  • Oversee operational aspects of all clinical studies company-wide and ensure deliverables are met.
  • Support project activities leading to building client relationships for defines customers and/or contracts.
  • Provide input into development of the planning and reporting framework based on and utilizing the core systems, internal KPIs and in line with external customer expectations.
  • Review KPIs tracked per project to monitor overall project delivery and client satisfaction and to take a proactive approach in management engagement and awareness of the project status.
  • Develop SOPs to govern the PM function, as needed.
  • Identify the need and support development of the Project specific SOPs, as needed.
  • Accountable for the financial management of the projects and assigned project portfolio.
  • Take part in the process and oversight of revenue recognition, project profitability, contract scope management and invoicing methodologies.
  • Represent PM function during QA audits.
  • Accountable for overall project and PM team members readiness for the QA audits
  • Complete CAPA in response to internally identified system/process weaknesses and/or customer complaints related to Clinical Operations.
  • Support to Business Development representatives for the development of appropriate solutions for customers individual needs and the closing and contracting of new business.
  • Drive operational elements of proposals and bid defense materials in collaboration with other team members.
  • Other responsibilities and ad hoc projects as required.

Supervisory Requirements: Position will have line management responsibilities.  Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention, performance appraisals, goal setting, and salary.

Position Qualifications/Requirements:

Education: 

Required: University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology.

Preferred:  Master’s Degree in scientific or business discipline.

Experience:

8+ years in a clinical research setting with a progression of increased responsibility over time, including 2+ years of management experience in a CRO setting with in depth knowledge of the project management activities.

Previous exposure to and experience of Oncology specific clinical development complexities.

Required Skills:

  • Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
  • Excellent written, oral communication and presentation skills
  • Excellent interpersonal and organizational skills with demonstrated attention to detail.
  • Ability to read, write and speak fluent English.
  • Ability to build positive, productive client and team member relationships.
  • Demonstrated management and problem-solving capabilities, strong critical thinking, and analytical skills.
  • Good computer skills with good working knowledge of a range of computer applications.
  •  Ability to meet deadlines, multitasks, and prioritize based on project needs.
  • Ability to make sound decisions based on available information.
  • Ability to work both in a team and independently.
  • Ability to lead team meetings and teleconferences and provide accurate and comprehensive minutes.
  • Ability and willingness to travel to investigator meetings, investigative sites and bid defense meetings, etc., up to 50%.

Working Conditions:

  • General office working conditions apply. Employee may be office or remote based.
  • Frequent travel for meetings or training activities may be required.

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