Demant

Oticon Medical - Clinical Project Manager (Clinical Trials)

Department Oticon Medical Other
Job Locations US-NJ-Somerset
Job ID
2021-10027

Overview

Oticon Medical is a global company in implantable hearing solutions, dedicated to the vision of making  life changing difference to people living with hearing loss (this is the official vision). We are part of the William Demant Group - one of the world’s largest groups of hearing health care companies with more than 11,000 employees worldwide and revenues of over $1.6B. We share a close link with Oticon hearing aid operations and have direct access to the latest advancements in hearing research and technologies. Our competencies span more than a century of innovations in sound processing and decades of pioneering experience in hearing implant technology. By working collaboratively with patients, physicians, and hearing care professionals, we ensure that every solution we create is designed with user needs in mind. We share an unwavering commitment to provide innovative solutions and support that enhance quality of life for people wherever life may take them. Because we know how much sound matters!

 

Oticon Medical is a global leader of bone anchored hearing aids and is one of the fastest growing companies in the medical device market. The team is knowledgeable and energized and is proud to employ members of the world’s leading pioneers in osseointegration. This expertise and attitude has positioned Oticon Medical with superior quality products, enormous know-how and solid access to the market through direct organizations, wholesalers and distributors.

 

The US market is one of the top priorities for Oticon Medical due to the size and the attentiveness for new technology and related support services. With the BAHS segment Oticon Medical has solid market position, but we expect that the company is able to further build share with the newly introduced Ponto 4 sound processor. We are also preparing FDA submission for our Cochlear Implant.

 

Oticon Medical will continue their market expansion, but more importantly continue the development of a new range of innovative implants, tools and support services to surgeons and audiologists.

 

Position Summary

 

The Clinical Project Manager (CPM) is responsible for the management of all aspects of clinical trial activities for assigned project(s). The CPM is accountable for clinical trial activities at the project level by meeting company and regulatory requirements according to time, quality, scope, and project budget.

Responsibilities

Primary Responsibilities to the Organization

  • Proactively manages project-level operational aspects of clinical trials, including management of trial timeline, project budget, resources
  • Provides clear updates on trial progress to Clinical Research Manager and other key project stakeholders
  • Leads sponsored study startup process, including but not limited to planning and execution of investigator meeting, the setup of trial master file (TMF), site selection, finalization of site and Clinical Trial Agreements, site budgets, and ethics committee submission
  • Ensures effective project plans are in place and operational for each trial
  • Ensures potential study risks are escalated to the attention of appropriate stakeholders
  • Identifies and assesses the suitability of facilities to be used as the clinical trial site
  • Communicates with PIs and study staff to ensure appropriate training and knowledge, answer questions, and obtain updates
  • Collects and reviews essential documentation prior to study initiation and during study to ensure regulatory compliance
  • Ensures all project-level study documentation is filed in the TMF in accordance with company SOPs and regulatory requirements
  • Contributes to the preparation of study protocols, informed consents, case report forms, and study support documents
  • Monitors the study/trial throughout its duration, which involves visiting the study, or working with CRO to meet all study needs
  • Verifies that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
  • Performs close-out visits to all study sites
  • Discusses results with a medical statistician and management
  • Archives study documentation and correspondence
  • Prepares final reports and occasionally writes, or contributes to manuscripts for publication
  • Reviews data management documents (data management plans, coding plans, etc.) for assigned studies
  • Maintains relevant accreditations required for the role
  • May perform miscellaneous tasks/projects as directed by manager

Qualifications

  • Bachelor’s degree, at minimum. Masters or Doctorate degree preferred
  • 3 or more years of clinical operations experience, in a medical, pharmaceutical, biotechnology, or CRO industry is required
  • Experience or knowledge of clinical trials related to medical devices required, Class III devices preferred
  • Detailed knowledge of current US FDA regulations relating to Good Clinical Practice and clinical trials
  • Excellent analytical, problem-solving, organizational, time-management, interpersonal and communication skills
  • Must be able to work independently and in a team environment
  • Ability to travel 30%
  • Excellent communication skills, both verbal and written, are required. Ability to solve problems. Must have effective time management and organizational skills

The Company is an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.

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