The LifeVest division of ZOLL Medical Corporation is dedicated to developing the LifeVest wearable defibrillator (WCD) and associated technologies. The LifeVest WCD, worn directly against a patient’s skin, is prescribed to patients at risk of sudden cardiac death (SCD). Every year, 350,000 American lives are lost to SCD. At ZOLL LifeVest, your work will help to ensure cardiac patients get the life-saving therapy they need.
We’ve 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 LifeVest the ideal place to build your career.
Position Summary: 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 team of CRAs 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.
Essential 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
- Participate in the design and review of clinical protocols, case report forms (CRFs), associated study documents, monitoring plans, and regulatory submissions and reports in collaboration with clinical management.
- Coordinate clinical data monitoring and database activities via a key relationship with project Data Management.
- Serve as an operational resource for internal team members for expedited problem identification and resolution, provision of site-specific updates and investigator activities, and CRO/Vendor interactions and deadlines.
- Provide regular clinical status information and to team members, including attending required meetings and following-up on action items.
- Ensure adherence to protocols, procedures, and project plans.
- Participate in identification, evaluation, and selection of investigative sites.
- Assists and/or manage activities and interactions with CROs/Vendors.
- Maintains all relevant documentation and communications as part of study files.
- Ability to coordinate or manage multiple projects across multiple centers and countries.
- Coordinates clinical site monitoring activities, and may participate in site monitoring associated with initiation, interim, close out, and audit visits as required.
- Conduct motivational visits, as well as, develop materials and initiatives to support patient recruitment and retention with each site.
- Adhere and assists 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.
- Reviews study data and resolution of queries, compile data for data review, create tables and graphs under appropriate guidance, and assist with 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.
- Performs other duties as assigned by Management.
- Ability to travel up to 30%, based on project needs.
Supervisory Responsibilities: Supervises and provides day to day work direction for project specific activities of CRAs.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
Educations and/or Experience:
- 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 of CRAs.
- At least 7years of Clinical Project Management experience
- Field Monitoring experience, preferred
- Strong working knowledge of medical/scientific terminology and knowledge of FDA regulations and 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
Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Mathematical Skills Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Reasoning Ability Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
- 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.
- 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.
ZOLL is an Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity.