North America-United States-North Carolina-Morrisville - 1400 Perimeter
The Site Start-Up Team Manager is responsible for the leadership and management of site start-up for an assigned group of studies. He/she directs the technical and operational aspects of the site start-up portion of assigned project. Works with major functional area leads (Project Management, Clinical Management, Clinical Administration, Legal, & Regulatory) to identify and evaluate fundamental issues pertaining to the successful site start-up of the projects, interpret data on complex issues, make good business decisions and ensure solutions are implemented.
The Site Start-Up Team Manager is, with support from the Directors, Associate Directors and/or other functional area leads, is accountable for ensuring that all project deliverables meet the customer's (PPD project teams, client) expectations and the contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments. Responsible for managing the work according to the portion of the project budget allocated to site start up. May be responsible for the line management, selection, training, coaching and performance management of staff.
Education and Experience:
Bachelor's Degree in life sciences (preferred)
Medical terminology and anatomy/physiology or licensed or certified health care training (e.g..: RN, MT, PA, RPh,)
Significant clinical research experience (comparable to 4+ years) including clinical management, study management, and start up experience.
Line management experience appropriate to the size and complexity of the Clinical Management- Site Start-up group in the designated country/region.
Or an equivalent combination of education and experience that provides the required knowledge, skills, and abilities to perform the job.
Knowledge, Skills and Abilities:
Demonstrated effective mentoring/leadership/supervisory ability including excellent interpersonal skills.
Demonstrated understanding of or ability to learn and demonstrate understanding of PPD SOPs, WPDs, and relevant regulations, e.g. ICH/GCP, FDA guidelines.
Demonstrated ability to evaluate medical research sites and demonstrate proficient knowledge of medical terminology.
Planning and organizational skills.
Ability to identify and manage risks related to contractual deliverables.
Ability to accurately report and analyze project specific data & systems to ensure contractual deliverables met.
Excellent problem solving, judgment and decision making skills.
Effective oral/presentation and written communication skills.
Excellent customer management skills.
Demonstrated negotiation skills.
Good financial awareness, ability to manage budget and resource allocation.
Possesses good interpersonal skills, self-motivated, and retains a positive attitude.
Excellent knowledge of FDA, ICH and GCP guidelines.
Strong attention to detail.
Able to promote a strong team approach and serve as a positive role model.
Able to supervise a diverse team and utilize the talents and abilities of all direct reports.
Able to effectively prioritize workload, and that of their team.
Competent use of computer to include data entry, archival and retrieval.
Ability to travel, as needed, for PSV accompanied field visits (AFVs).
PPD is an Equal Opportunity Employer
Pharmaceutical Product Development, Inc. - 2 years ago
PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services....