Clinical Trial Manager - Gene Therapy in Cambridge, MA at APEX Systems

Date Posted: 2/12/2020

Job Snapshot

Job Description

Job #:  1047845
Clinical Trial Manager, Gene Therapy 1047845
Job Scope & Purpose:
Our Boston based client, focusing in gene therapy, is expanding their clinical operations team and seeking an experienced Clinical Trial Manager (CTM) to join a growing team! The chosen individual will contribute to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs.
Primary Job Responsibilities:
  • Key support role to the Project Manager; manages components of clinical trials and, with minimal direction and oversight, ensures that they are executed to specified quality standards.
  • In addition to responsibilities related to quality control, provides project management support on budget and timelines, vendor oversight and site management
  • Contributes to TMF QC plan development and performs QC of TMF; creates, maintains, and closes out TMFs
  • Thoroughly understands clinical trial protocols and site specifications and manages the oversight of the data delivery process in clinical trials ensuring consistency with protocols, including participation in data review/ reconciliation efforts
  • Manages elements of the quality plan (e.g., inspection readiness, compliance); diligently follows Clinical Development Operations SOPs; identifies gaps, and works with other senior Clinical Development Operations staff or independently to eliminate those gaps
  • Manages aspects of the relationship with CROs and/or trial sites; works with CPM or other Clinical Development Operations senior staff to resolve issues or problems with the sites
  • Supports the PM in the set-up, conduct, and closeout of clinical study activities - e.g. Central Lab and ancillary vendors

Primary Job Requirements:
  • The successful candidate will meet the following requirements.
  • B.S. and/or M.S. degree in a scientific discipline and at least three (3) years of clinical research experience.
  • Demonstrates advanced knowledge of and appropriate experience of relevant software packages (e.g. Microsoft Project, Word, Excel) and the company’s systems and programs. 
  • Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
  • Learns, interprets, and explains protocol requirements to others.
  • Manages components of clinical trials independently with limited general guidance from senior staff.
  • Demonstrates deep understanding of interdependencies of data, technology, vendor systems and metrics and differences across vendor abilities and requirements.
  • Strong verbal, written and presentation skills.

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
jprice@stratacuity.com
Code: ClinOps
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.