Clinical Trial Operations Manager in Bridgewater, NJ at Apex Life Sciences

Date Posted: 5/25/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    5/25/2018
  • Job ID:
    852987

Job Description


The Clinical Trial Operations Manager (CTOM) is responsible for part of the operational aspects of clinical trial oversight including the delivery of every study on time within budget and scope in compliance with GCP’s, SOPs and standards.

Responsibilities

  • Provide oversight on study activities to ensure progress according to study timelines
  • Support the Senior Lead CTOM and/or Lead CTOM in taking study logistic decisions and implementing operational plans upon endorsement by the study team
  • Ensure proper documentation availability
  • Ensure proper collection and validation of data and documentation on a timely manner
  • Organize and lead study meetings
  • Collect, synthesize and report study information
  • Collaborate with the Clinical Supplies Platform to validate Investigational Medicine Product (IMP) needs, specifications, packaging, shipment including resupply and reconciliation process
  • Participate in selection and management of vendors, development and follow-up of the associated budget
  • Preparation and oversight of study audits/inspections both internal and external
  • Provide oversight and preparation for FDA pre-approval inspections (PAI)
  • Participate in the training of new CTOMs on therapeutic area and general responsibilities within their function

Qualifications: 

  • Bachelor's degree required; Advanced Degree in scientific discipline preferred, equivalent RN
  • 2+ years of experience in the pharmaceutical industry or clinical-related discipline including 1+ years of clinical research experience a must
  • 3 years of experience in pharmaceutical industry, 2+ years clinical research experience and 1+ years of prior management and/or supervisory experience in coordinating vendors, budget management or country management preferred
  • Ability to manage and lead international meetings such as Study Teams
  • Ability to work cross-functionally fostering team spirit and team motivation  (e.g. study team or transversal project team)
  • Good Project coordination skills and organizational skills including attention to details
  • Ability to develop and maintain an optimized study planning with other functions (including identification of critical path)
  • Ability to handle multiple tasks, prioritize activities
  • Ability to anticipate, timely escalate issues and to define appropriate action plans
  • Ability to work autonomously to efficiently and effectively provide status reports
  • Participation to routinely data management activities and oversight, data review and analysis (clinical operational) to propose actions and a remediation plan
  • Good written and verbal communication skills, including negotiation skills
  • Alert on purpose, communicate on issues with proposed action plans
  • Ability to adapt communication, address the right topics and adapt content/level of details to the right recipients, select topics to be addressed internally first
  • Experience in the management of vendors for outsourced activities is preferred
  • Ability to work in an international environment with internal and external partners such as vendors, database designers, and programmers
  • Ability to learn from experience and develop a change mindset
  • May assist trainees, Clinical Project Assistant, Trial Management Assistant, and new comers in their self-development
  • Knowledge of International Standards (e.g. GCP, CDISC, etc.), company tools, processes and SOPs,
  • Good working knowledge of Microsoft Office a must

EEO Employer

Apex 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. 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 employeeservices@apexsystemsinc.com or 844-463-6178.