at Terumo BCT
Posted on Sep. 7, 2016
CLINICAL TRIAL MANAGER
Manages operational implementation of both pre- and post-market clinical trial(s) in the US and/or globally. Assists with development and ensures adherence to study budget and timelines. Ensures compliance with the Clinical Investigation Plan (CIP), applicable regulations, and established SOPs/processes. Recommends and implements innovative process ideas to positively impact clinical trial management. Provides training and mentorship to study team members. Acts as a cross functional liaison to ensure implementation of discreet trial tasks. Functions primarily within defined practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Manages the operational aspects of clinical trials including document development, investigator recruitment, patient enrollment, trip report review, study trackers, study specific guidelines/processes
* Author/review/revise study documents such as Informed Consent Form templates, Study Management and Monitoring Plans, Clinical Project Plans, site training materials, Case Report Forms
* Develop and initiate feasibility studies and patient recruitment strategies
* Ensures adherence to timelines and budget. Assists with development and manages overall clinical trial budget and study site budgets.
* Reviews documents such as Clinical Investigation Plans, Clinical Investigation Reports
* Participates in determining outsourcing strategy and vendors selection. Manages vendors
* Primary contact for study team members and external vendors - delegates as appropriate
* Conduct or participate in study site visits, as necessary
* Coordinates the investigation of serious/unanticipated drug or device related adverse events, device deficiencies, and protocol deviations and ensures follow-through
* Assures quality and integrity of clinical trial data by monitoring patient status during the course of the study ensuring quality of data collection and alerting applicable personnel if safety or study conduct issues are identified. Assures that monitoring visits are scheduled at appropriate time intervals and adjusted to manage various patient accrual rates. Assure that CRAs manage sites to ensure timely, accurate collection of data and query resolution. Tracks data query rates; identifies and provides solutions for data trends
* Ensures maintenance of the Trial Master File
* Coordinate efforts of cross-functional project team
* Maintains knowledge of relevant regulations and guidelines and ensures compliance with GCP standards, applicable regulations (eg, CFR, ISO-14155), Standard Operating Procedures (SOPs), and study specific documents, processes, policies, and procedures. Coordinates and ensures consistency of study specific templates/guidelines
* Identifies ongoing training and development needs of staff. Provides training, guidance, and mentoring to study team members.
* Coordination of investigator meetings and development of presentation materials, as applicable
* Foster positive working relationships with key investigators, vendors, and collaborators
* Maintains awareness of overall development in the field of clinical research based on current literature, attendance at professional meetings, continuing education, etc.
* Prepare and present project information at internal and external meetings (eg, study site, vendors)
* May draft or revise clinical SOPs
* Ensures studies are posted and updated on clinicaltrials.gov as required
MINIMUM QUALIFICATION REQUIREMENTS
* Knowledge necessary to perform in the position generally acquired through, at a minimum, a Bachelor's degree in nursing or biological sciences or in a related scientific discipline, or equivalent
* At least 3 years of experience in managing clinical trials in the medical device, diagnostic or pharmaceutical industries. Global experience preferred
* Self-directed with ability to work independently
* Has a thorough understanding of applicable GCP, CFR, ISO regulations
* Effective leadership and cross-functional skills within a team
* Positive and a proactive approach to identification and definition of problems, and with the development and implementation of solutions
* High level of adaptability, initiative, and willingness to take ownership and accept responsibility for actions and decisions
* Strong interpersonal skills and the ability to represent the business with both internal and external colleagues associated with the organization
* Excellent organizational, written, and oral communication skills, and proven ability to establish working relationships with all levels of clinical/technical/regulatory/marketing teams, in a corporate, clinical, and academic setting
* Demonstrate diplomacy and tact while maintaining appropriate assertiveness and persistence
* Competent in Microsoft Office
* 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
* In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds
* US or International travel may be required up to 50%
We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace.