Acelity Careers

Manager, Clinical Project Management

United States of America
Science and Engineering

Job Description


The Clinical Project Manager is accountable for operational oversight in the development, execution and closure of a clinical study in accordance with the study protocol, department operating procedures (SOPs), ICH-GCP and applicable regulatory requirements.

Major Responsibilities:

  • Direction, planning and initiation of clinical studies;
  • Operational responsibility for ongoing clinical studies including fiscal oversight, study timelines through completion of the clinical study report;
  • Integration of subject matter experts into the clinical study processes;
  • Oversight of planning, execution and interpretation of clinical studies in compliance with appropriate regulatory and medical standards;
  • Direct the development of written documents, such as: clinical study protocols, clinical study reports, abstracts, peer-reviewed literature, and other relevant documents;
  • Develops relationships with investigators and key opinion leaders;
  • Assesses feasibility of incoming research proposals;
  • Tracks project information including patient enrollment, monitoring visits, completion of reports, and budget;
  • Set- up and coordination of all activities for service consultants/CRO’s;
  • Develops Informed Consent Forms, data collection tools and other study specific documents necessary for the appropriate implementation and conduct of clinical studies;
  • Assures the creation of study specific monitoring and communication plans and updates as appropriate;
  • Responsible for creation and tracking of study budget as well as site budgets, payments and contracts;
  • Responsible for the identification of sites and Investigators;
  • May perform co-monitoring visits at participating sites or CRO’s, to ensure compliance with the protocol and appropriate regulations, guidelines and SOPs;
  • Assures the organization of investigator meetings, data monitoring committee meetings, steering committee meetings, as appropriate;
  • Oversees and ensures timely, accurate collection of (Serious) Adverse Events, (S)ADEs and/or complaint reports and follow up in close cooperation with the Clinical Safety Department;
  • Prevents, identifies, resolves and/or escalates issues identified through analysis of study data, trends and reports;
  • Participates in the development of departmental procedures, demonstrating in-depth knowledge of clinical trial processes;
  • Participates in all reasonable work activities as may be deemed suitable and assigned by management;
  • Interface with study team members on an ongoing basis and provides guidance and direction on clinical trial issues, monitoring issues;
  • Responsible for managing Clinical Operations resources and providing oversight to staff to achieve functional goals including:
    • Providing training, coaching and mentoring of Clinical Operations staff
    • Reviewing reports, approving travel, assessing compliance with monitoring plans, procedures and regulations and evaluating performance
  • Provides quality review of clinical study documentation to ensure study compliance with department operating procedures, GCP and applicable regulatory requirements

Position Qualifications


  • Minimum of 8 years experience in clinical research, 1-3 years of clinical project management experience preferred  
  • In-depth knowledge of ICH GCP, FDA regulations (medical device preferred)


  • Bachelors degree in sciences/life sciences or other health care related field.
  • Masters or higher preferred. 


  • Ability, willingness and flexibility to travel up to 20%
  • Ability to deal effectively in all business relationships while projecting a positive image of the company
  • Hands-on mentality and a solution-oriented and pro-active attitude
  • Work independently, or in a team environment with minimum supervision
  • Ability to prioritize and perform multiple tasks
  • Apply sound judgment and decision making
  • Ability to understand basic statistical design and analyses
  • Ability to communicate effectively, both verbally and in writing
  • Fluent in English
  • Excellent working knowledge of MS Office (Word, Excel, Power Point and MS Project)
  • Strong communication and interpersonal skills
  • Have a broad understanding of clinical trial processes
  • Knowledge of medical terminology/ therapeutic area specialty
  • Ability to completely maintain confidentiality and discretion in business relationships and exercise sound business judgment
The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: VEVRAA Federal Contractor