Clinical Trial Manager - Seattle Genetics

Position Description

If you are looking for a stimulating environment where discovery and development of therapies to treat cancer patients is the central goal, we are interested in hearing from you! We are looking for a highly motivated individual to join our team as our Clinical Trial Manager.

This position has three primary responsibilities: Execution of the monitoring functions of a clinical trial (e.g. those functions having to do with the site), Management of staff within the clinical trial management group, and development of standards and practices within the CTM group.

DETAILED DUTIES & RESPONSIBILITIES:

Project Responsibilities

· Coordinate and manage vendor processes for the monitoring function of clinical projects including central laboratories.

· May act as Protocol Lead on one or more projects

· Primary contact for CROs Clinical Monitoring Team to ensure their performance to the terms of contract, ICH/GCP adherence, and overall quality of work.

· Coordinates day-to-day activities for the monitoring function of clinical studies including flow of documents and information to and from sites and/or external vendors

· Facilitate the flow of information between contract CRAs, CROs and in-house team members and other involved members of the department and Seattle Genetics.

· Develops quality control program for each clinical trial and oversees implementation (i.e. co-monitoring, periodic review of adherence to monitoring plan, etc.).

· Oversee drug accountability system, including management of drug accountability for a study.

· Responsible for the quality and deliverables of the CRAs.

· Will be the Clinical Operations member responsible for the design and review of clinical studies/protocols in collaboration with senior management, medical monitor, biostatistician, and regulatory affairs.

· Participate in the creation and tracking of detailed monitoring plans for clinical projects.

· Participate in the evaluation, training and refining of departmental SOPs and guidelines, and the development of standard reports, templates and forms

· Problem-solve clinical study and related personnel issues.

· Participate in Identification, evaluation and selection of clinical investigators and investigative sites.

· Collaborate with Supply Chain to coordinate drug supply and final study level drug accountability .

· Maintain detailed site and patient information for assigned sites via Seattle Genetics electronic clinical trial management system



Management

Train and mentor clinical staff in study management and GCP

· Manage internal (dotted line or functional) and external CRAs, and other external vendors as necessary.

· Serve as mentor to help staff develop their career paths

· Provide timely feedback to staff on personal and project performance and guide them in course correction and performance improvement

· Empower and coach staff members to accept responsibility for their work, manage themselves and excel at their assigned projects

· Perform performance evaluations twice per year to provide staff with constructive feedback to enhance their performance

· Establish and enforce department and corporate goals with staff

· Review and revise staff project assignments as needed to balance workload

· Ensure staff training is adequate and documentation of training is up to date.



Infrastructure Development/Maintenance

· Should assume responsibility for development and maintenance of some group SOPs or Processes

· Should become subject matter expert for complex processes within the clinical trial management group

· Assume responsibility for maintenance and update of job descriptions for the group

· Responsible for initiating and manging the hiring process for assigned open job positions

· Work with director to set goals for the CTM group and manage group to achieve goals

REQUIREMENTS:

· 9+ years clinical trial management experience or equivalent, including 5 yrs CRA/CRO management experience or equivalent. Experience in the Pharmaceutical Industry is required.

· Bachelors in scientific discipline, RN or health care professional or equivalent. An advanced degree is a plus

· Experience managing CRO relationships

· Oncology and Hematology Clinical Research experience preferred

· Past experience working in both a CRO and /or sponsor a plus

· Experience managing personnel is required.

· Ability and willingness to travel is required (domestic and internationally)

· Thorough knowledge of European Clinical Trial Directive required.

· Thorough knowledge of FDA and ICH requirements

· Understand clinical drug development process

· Proficient in development of clinical tools and documents

· Excellent communication and organization skills

· Excellent Clinical monitoring skills

· Ability to Plan, organize and conduct clinical studies with minimum oversight

How to Apply