Acelity Careers

Clinical Project Manager

San Antonio, United States of America
Science and Engineering


Job Description

The Clinical Project Manager is accountable for the set-up, execution and closure of a clinical study conducted and/or managed by KCI in accordance with the protocol, Standard Operating Procedures (SOPs), ICH-GCP,  local regulations and applicable regulatory requirements. This position involves coordination and supervision of the clinical research projects including development of the study protocol, CRF design, study conduct, statistical planning and analysis, and development of the clinical study report.  The Clinical Project Manager may assist in the support the Investigator Initiated Study (IIS) program and act as a contact for selected sites.

Principle Responsibilities: (essential job duties and responsibilities)

  • Responsible for the identification of sites and Investigators;
  • Develops relationships with investigators, key opinion leaders, and research institutions;
  • Set-up and coordination of all activities for service consultants, CRO’s or other vendors which may assist KCI during the execution of a study;
  • Assures the creation of study specific plans (e.g. Overall Study Project Plan, Statistical Analysis, Monitoring and Communication plans) and updates them as appropriate;
  • Develops Informed Consent Forms, data collection tools and other study specific documents necessary for the appropriate implementation and conduct of clinical studies;
  • Tracks project information including patient screening and enrollment, monitoring visits, budgets and payments;
  • May perform monitoring or co-monitoring visits at participating sites, CRO’s or other vendors, 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;
  • Ensures timely, accurate collection of (Serious) Adverse Events, (S)ADEs and/or complaint reports and follow up
  • Prevents, identifies, resolves and/or escalates issues identified during clinical trial activities;
  • Interface with study team members on an ongoing basis through giving guidance and direction on clinical trial issues, monitoring issues;
  • May support IIS sites during start-up and for the course of the study through publication
  • Supports the implementation of new clinical regulations and guidelines
  • Participates in the development of departmental procedures, demonstrating in-depth knowledge of clinical trial processes;
  • Provides quality review of clinical study documentation to ensure study compliance with department operating procedures, GCP and applicable regulatory requirements;
  • Participates in all reasonable work activities as may be deemed suitable and assigned by management;

Experience:

  • Minimum of 6 years experience in clinical research, 3 years of experience as a Clinical Research Associate  
  • In-depth knowledge of ICH/GCP, Title 21 of the Code of Federal Regulations and/or ISO 14155
  • Wound healing experience preferable; familiarity with wound healing literature and protocols

Competencies/Values:

  • Ability, willingness and flexibility to travel up to 30%
  • 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, bilingual preferred
  • Excellent working knowledge of MS Office (Word, Excel, Power Point)
  • Broad understanding of clinical trial processes
  • Strong interpersonal skills
  • Knowledge of medical terminology/ therapeutic area specialty
  • Analytical and accurate
  • Ability to completely maintain confidentiality and discretion in business relationships and exercise sound business judgment

Minimum Qualifications:

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

Preferred Qualifications:

  • Masters or higher preferred.
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: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor