Manager, Clinical Research in Plainsboro Township, NJ at Apex Life Sciences

Date Posted: 6/20/2018

Job Snapshot

Job Description


Apex Life Sciences is looking for a Clinical Research Manager to join our World Leading Medical Technology Company.

The ideal candidate will have five to seven years’ experience in clinical research, and a proven track record of conducting clinical research studies in a hospital setting, medical device and/or pharmaceutical company, or CRO. Must have been in a lead or supervisory position previously.

This is a permanent opportunity, and is on site only.

For immediate consideration, please send resumes to: mbingham@apexlifesciences.com

Description:

  • Coordinates clinical operations including: Design, initiation, coordination of clinical trials to support regulatory submissions, as well as post-market clinical trials. In case of CRO managed studies: Leads CRO evaluation and selection process, and provides ongoing CRO oversight.
  • Coordinates the preparation of state-of-the-art study documentation, including: protocol, statistical data analysis plan, monitoring plan, informed consent form, case report form, investigator agreement and financial agreement, as required.
  • Ensures compliance with all applicable regulatory standards related to clinical trials and interactions with physicians. Continues to increase knowledge of medical device development process, ICH-GCP, FDA regulations and any other applicable local/international regulatory requirements.
  • Assists in updating corporate Standard Operating Procedures (SOPs) to support adherence to company policies and procedures concerning Clinical Affairs, in coordination with Global Clinical Affairs team members.
  • Responsible for the financial management of the clinical trial program including budget planning, resource allocation preparation of quarterly reports and investigator payments as applicable.
  • Supports data collection, assessment and reporting activities. Works closely with Data Management for the design and execution of appropriate data management practices, including the use of electronic data capture (EDC), and clinical trial management systems (CTMS).
  • Works collaboratively with Medical Writers for the writing and editing of manuscripts, protocols, IDE submissions, CSRs, outlines, tables, and figures for clinical publications.
  • Interfaces with Global Clinical Affairs, Legal, R&D, Marketing and Sales to ensure that clinical activities are in line with overall strategic goals.
  • Supports regulatory affairs personnel with clinical sections of regulatory submissions, and study related communication with regulatory agencies. Collects, reviews and tracks regulatory documents when required.
  • Ability to travel 20% to 50% of time.  

Requirements:

  • Bachelor’s Degree in Life Sciences. Advanced degree (PhD, PharmD, MPH, MBA) is a plus.
  • Five to seven years’ experience in clinical research required, preferably in medical device industry.? Proven track record of conducting clinical research studies in a hospital setting, medical device and/or pharmaceutical company, or CRO.
  • Must have been in a lead or supervisory position previously. This is a direct hire position, and is on site only.   
  • Strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships.
  • Detail oriented, excellent organizational and management skills.
  • Position requires composition ability, data analysis skills, scientific writing and presentation skills
  • Expert in design and development of scientific research protocols, clinical investigational plans, and regulatory strategies. Thorough knowledge of FDA guidelines and regulations, ICH guidelines and Good Clinical Practices (GCP) governing the conduct of clinical trials.
  • Experience in collaborations with relevant trade organizations, as well as hospitals and physicians.

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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.

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.