Director of Clinical Research Regenesis Biomedical
THIS JOB HAS EXPIRED Level: ExperiencedSalary Range: Undisclosed
Job Location: US-AZ-ScottsdaleTravel %: Up to 25%
Position Type: Full TimeJob Shift: Day
Education Level: 4 Year DegreeJob Category: Research
The Director of Clinical Research (DCR) is responsible for the development and implementation of the clinical trial strategy and directing all clinical study activities including planning, operations and reporting. The DCR ensures efficient execution of trials within established budgets and timelines, and compliance with appropriate regulations, including FDA, privacy, and ICH requirements. The DCR is responsible for on-label post-market descriptive and investigational studies, as well as pilot and pivotal studies supporting regulatory registration. The DCR will coordinate the efforts of internal and external resources to ensure sound study design, careful site selection, rapid subject recruitment, trial plan optimization and execution of trials with a focus on quality, innovation and efficiency. Most studies will be conducted in-house by the clinical research staff; some studies may involve partnering with CROs.
ESSENTIAL DUTIES & RESPONSIBILITIES
Collaboration with IT department in the maintenance and application of the in-house EDC system
Development and management of in-house sponsor investigative site
Collaborates with Reimbursement and Marketing to ensure integration of health economic and outcome measures into clinical trials
Ensures operation is within approved budget and timeline
Ensures all activities comply with applicable regulations and company SOPs
Other responsibilities as determined by Management
KNOWLEDGE & SKILL REQUIREMENTS
Strong knowledge of FDA medical device regulations, Federal and State law governing clinical research including human subject protection and HIPAA, and experience with IDE Trials. Knowledge of Good Clinical Practice (GCP) is required.
Ability to work well independently as well as a member of multiple, integrated teams.
Strong project planning, project management, leadership, negotiation, technical writing and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
Ability to multi-task and manage several projects in parallel, paying attention to detail. A wide degree of creativity and latitude is expected.
Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion.
Outstanding communication skills, oral and written required.
Superior writing skills and ability to effectively communicate with technical and non-technical people.
Strong MS Office (Word, Excel, PowerPoint) skills.
Knowledge of and experience in experimental design.
Substantial understanding of statistics and statistical methods.
Show Drive & Initiative: Establishes aggressive goals and drives for results; readily puts in extra time and effort; tackles problems and works to resolve them without delay; establishes high standards of performance
Show Adaptability: Responds resourcefully to new demands and challenges; works effectively in ambiguous situations; adapts behavior in response to feedback and experience; deals constructively with own failures and mistakes
Act Strategically: Balances big-picture concerns with day-to-day activities; stays informed about industry practices and new developments; understands the organization?s mission and strategies.
Develop Others: Attracts high caliber talent; gives clear, motivating and constructive feedback; provides challenging assignments to facilitate individual development; willingly shares expertise and experience with others.
Displays Organizational Savvy: Develops effective give and take relationships with others; understands the agenda and perspectives of others; recognizes and effectively balances the interest and needs of one?s own group with those of the broader organization.
Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality.
Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses.
Innovation: Generates new ideas; goes beyond the status quo; recognizes the need for new of modified approaches; brings perspectives and approaches together combining them in creative ways.
EDUCATION, EXPERIENCE & TRAINING REQUIRED
Requires a BS, or BSN degree, or equivalent; advanced degree preferred.
At least 7 years of experience in the pharmaceutical, biological or medical device. industry as a clinical research professional, including a successful project leadership role and hands-on managerial experience running clinical trials and managing personnel.
Medical device clinical trial experience and pain trial experience is strongly preferred.
PMA and IDE experience is strongly preferred.
Health economics and data management experience preferred.
Hands-on experience in development and/or management of investigational sites is preferred.
Must be able to operate personal computer and printer
Able to work standard office equipment (photocopy machine, fax machine, etc.)
Ability to work on a computer up to 8 hours a day.
Ability to travel up to 25% of the time in vehicles, airplanes and other modes of transportation, with some travel on weekends, as necessary.
||1435 North Hayden Road |
Scottsdale, AZ 85257
THIS JOB HAS EXPIRED