Clinical Research Project Manager

Location: Pittsburgh, PA

Cardiac Management Solutions

The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.

Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives.

ZOLL has been Pittsburgh’s Manufacturer of the Year, one of Western PA’s Healthiest Employers, and even one of Pittsburgh’s Coolest Offices. But it’s our unique opportunity to impact people’s lives that makes ZOLL the ideal place to build your career.

Job purpose                                                                                                                             

The Clinical Project Manager serves as an operational point person in the execution of clinical studies. The CPM oversees the daily operations and management of a clinical research team for multi-center studies both inside and outside the United States. The CPM works closely with internal functional team members, CROs/Vendors, collaborators, and participating sites to ensure that clinical studies are conducted in a timely manner to achieve study goals within defined budgets. The CPM supports the Director in achieving study goals for protocol submission and approvals, site initiation, source document verification and data monitoring, device accountability, clinical database lock, and site closure. By overseeing the day-to-day operations of multiple clinical trials

  Duties and responsibilities                                                                                                     

  • Oversee the day-to-day management of multiple trials to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
  • The CPM supervises and provides day to day work direction for project specific activities of CRAs and other study team members.
  • Participate in the design and review of clinical protocols, case report forms (CRFs), associated study documents, , and regulatory submissions and reports in collaboration with clinical management.
  • Develop study plans
  • Coordinate clinical data monitoring and database activities via the clinical monitoring and data management teams.
  • Serve as an operational resource for team members for problem identification and resolution, provision of site-specific updates and investigator activities, and CRO/Vendor interactions and deadlines.
  • Facilitate regular clinical status information flow between team members, including attending required meetings and following-up on action items.
  • Ensure adherence to protocols, procedures, and project plans.
  • Oversee identification, evaluation, and selection of investigative sites.
  • Manage activities and interactions with CROs/Vendors.
  • Maintain all relevant documentation and communications as part of study files.
  • Coordinate clinical site monitoring activities, and may participate in site monitoring associated with initiation, interim, close out, and audit visits as required.
  • Provide Site motivational visits, as well as, develop materials and initiatives to support project wide patient recruitment and retention.
  • Adhere and assist with the development and facilitation of clinical documents including informed  consent  forms,  case report  forms,  study  manuals,  Standard  Operating
  • Procedures, and other clinical materials to ensure compliance with regulatory, IRB, and company policies.
  •  Oversee the review of study data and resolution of queries, compilation data for data review, creation of                         tables and graphs, and oversees the preparation and review of clinical study reports.
  •  Facilitate/prepare technical reports, summaries, and quantitative analyses.
  • May travel to study sites based on project needs.
  • Perform other duties as assigned by Management.
  • Ability to travel up to 30%, based on project needs.

 

 

Qualifications

  • BA/BS in a clinical, scientific, or related field or equivalent experience
  • Advanced degree in a scientific discipline or at least 3 years equivalent experience in medical device industry
  • Experience and responsibilities in study team leadership and management.
  • At least 2 years of Clinical Project Management experience preferred
  • Strong working knowledge of medical/scientific terminology and knowledge of FDA regulations and ICH-GCP guidelines is required.
  • Knowledge of field-based monitoring procedures
  • Knowledge of legal and regulatory landscape concerning clinical research
  • Professional use of the English language, both written and oral
  • Excellent organizational skills with attention to detail
  • Demonstrated proficiency in implementing, monitoring, and management of clinical trials (start-up to close-out)
  • Ability to work with minimal supervision once given instructions

  Working conditions                                                                                                                 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually quiet.

  Physical requirements

The physical demands described here 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.

While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.

  Supervisory responsibility                                                                                                      

No Direct Supervisory Responsibility

  AAP/EEO Statement                                                                                                                  ZOLL is committed to fostering an inclusive workplace, where unique identities, backgrounds, cultures, perspectives and experiences are respected and valued.

Equal Opportunity Employer – Disability and Veteran

 

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