General Information

Location: Munich, Bavaria

Organization: Medavante-Prophase, Inc

Job Type: Full Time - Regular

Description and Requirements

The Clinical Assessment Manager works in a pivotal role of managing communication and activities among clinical research sites, Investigators, and WCG MA-PP clinicians to prepare for and  complete clinical assessments in accordance to the project specific scope of work.

  • Bachelor’s Degree in health care, life sciences or related field with demonstrable related experience in pharmaceutical / biotechnology industry. CNS clinical trials experience is an advantage.
  • At least five (5) years of previous research experience and/or clinical experience is required.
  • Ability to read, understand and assimilate protocol specified requirements and/or to ask appropriate questions as needed to gain knowledge and understanding.
  • Must possess knowledge of research design, patient care practices, GCPs, FDA regulations and a thorough knowledge of medical terminology.
  • Experience with an eCOA platform is a plus.
  • Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.
  • Ability to communicate and work effectively with a diverse team of professionals.
  • Excellent organizational, prioritization, time management skills are required, detail-oriented, people-oriented, self-confident, flexible and adaptable to change.
ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.
  • Partner with project management, clinical science and eCOA teams to develop and implement project specific processes to successfully deliver the services as outlined in the scope of work related to clinical assessments.
  • Ensure the Company standards and expectations in the Clinician Services are met and adhered to as measured by visit availability, wait times, clinician utilization, and safety reporting compliance.
  • Responsible for the resourcing of Principal Clinician (internal and external) ensuring that the study protocols scheduling of study assessments with sites and clinicians are met.
  • Prepares presentations and conducts training of Investigators at Investigators´ Meetings and SIVs, or at any stage during the trial, when required.
  • Develop project specific manuals for the clinical assessment services as outlined in the scope of work.
  • Mitigate risk related to clinical assessments as outlined in the project specific scope of work.
  • Onboarding new clinical sites to the scheduling system and project specific assessment services
  • Track and report progress of project, including subject, site and clinician compliance, scheduling metrics, risk related metrics
  • Monitor site compliance with subject visits as outlined in the study protocol
  • Monitor query notification and resolution process with sites to ensure and protect data integrity
  • Support reviews of clinical data in conjunction with the Clinical Scientist to perform clinical data risk assessments
  • Monitor reports to track subject visits and ensure compliance with risk reporting processes
  • Developing/Writing site facing documents as well as internal project plans specific to the clinical assessment services provided as detailed in the project specific scope of work
  • Onboarding sites with project start up, including testing of equipment, mock assessments, and closeout activities related to clinical assessments
  • Review protocols to support custom report generation for monitoring and tracking of data captured in the clinical eCOA system
  • Develop project specific training materials for sites, as well as internal clinicians in conjunction with WCG MA-PP subject matter experts
  • Supporting sites, investigators, and clinicians with clinical assessment compliance
  • Monitoring for the alerting of Investigators/Sites, Clients and the Clinical Science team and designated personnel when a patient risk has been reported and ensuring that the risk has been acknowledged by both the Investigator/Site and Client.
  • Development of workflow procedures for study team based on specific project and study protocol.
  • Serve a primary point of contact for Clients, Investigators/Sites by interacting in a positive professional manner.
  • Actively practice and maintain adherence to FDA regulations and regulatory guidelines in all aspects of conducting clinical trials.
  • Contribute to fostering team spirit and productivity by establishing communication lines within the project team.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Attendance and punctuality are essential functions of the position.
SUPERVISORY RESPONSIBILITIES: Supervise and manage clinical assessment coordinator(s) and support staff as the company expands.

TRAVEL REQUIREMENTS: This role may require up 20% travel which may be domestic or international, including overnight and weekend stays, consistent with project needs and office location.