This is an exciting opportunity to work to develop clinical trial protocols, manage and monitor clinical study activities and assure adherence to SOPs and study protocols at several study sites. You will work with a wide variety of key groups and individuals including investigators, contract vendors, research organizations, doctors and patients. At these sites, you will represent ImpediMed as the global leader in Bioimpedance Spectroscopy (BIS) technology and promote ImpediMed’s core values in the business world.
ImpediMed is the world leader in the development and distribution of medical devices employing Bioimpedance Spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status. ImpediMed’s primary product range consists of a number of medical devices that aid surgeons, oncologists, therapists and radiation oncologists in the clinical assessment of patients for the potential onset of secondary lymphedema. ImpediMed has the first medical device with an FDA clearance in the United States to aid health care professionals clinically assess secondary unilateral lymphedema of the arm and leg in women and the leg in men. As we expand we will require new employees to help develop and market our compelling product range.
ImpediMed also markets devices for body composition assessment and fluid status monitoring in a variety of research settings. ImpediMed is developing its BIS technology for use in many other clinical settings.
ImpediMed is an ASX 300 company, and one of the fastest growing small companies on the Australian Stock Exchange.
Visit our website at: www.ImpediMed.com and our stock at ASX:IPD
TO APPLY: Please on email: email@example.com, subject line reading: Clinical Trials Manager
ATTENTION CANDIDATES: Along with your resume, please provide a cover letter explaining your interest in this job opportunity and why you are interested in working at ImpediMed.
The Clinical Trials Manager, under the direction of the SVP Medical Affairs, executes activities to ensure the adequacy and efficiency of the company’s clinical initiatives.
PRIMARY DUTIES & RESPONSIBILITIES: (Essential Functions of the Position) include, but are not limited to the following. Other duties may be assigned.
• Manages overall operation of the entire clinical study including project planning, budget negotiation, resource management, institutional review board, legal agreement with sites and purchasing
• Collaborates and coordinates with others to design and implement clinical protocols and data collection systems
• Develops study related documents and provides direction for the clinical sites to establish protocol development
• Uses statistical analysis systems, such as SAS, as appropriate
• Ensures compliance with/and training for good clinical practices, good documentation practices, and regulatory guidelines, ensuring adherence to domestic and global regulations
• Recommends and implements innovative process ideas to impact clinical trials management
• Manages clinical budget and develops contingency plans for clinical trials
• Responsible for managing full scope of study, protocol and scientific publications
• Acts as a cross functional liaison to ensure study plan aligns with business development and R&D strategies
• Develops systems for organizing data to analyze, identify and report trends
• Addresses data management issues by reviewing protocols for cross-project consistency and identifying standard case report form modules to meet objectives
• Develop data quality plans
• Provides early strategic input into protocol design focused on data management issues
• Reviews and resolves data discrepancies – both in-house and at sites for standardized data validation systems and procedures
• Responsible for tracking and management of study materials, including devices, in conjunction with R&D
• Conduct or participate in research activities for new methods of measurement and analysis in pursuit of ImpediMed’s marketing and clinical goals
• Write, or assist in writing as required, research papers for publication
• Co-Authors Clinical section of FDA pre-submission
• Act as representative for ImpediMed installed at the Mayo Clinic, Rochester, MN onsite several days per week (per Mayo/ImpediMed agreement)
QUALIFICATIONS GUIDELINES: (Knowledge, Skills, & Abilities)
• Must understand, follow and comply with regulatory requirements as applicable to various processes. An understanding of FDA Quality System Regulations and ISO Standards (ISO 13485) is required.
• Must possess a thorough understanding of work related standards and regulations, including but not limited to Standard Operating Procedures (SOPs) and Quality System Regulations (QSRs), both US and international.
• Experience with CRO/CRA management and overall life-cycle clinical trials
• Ability to read, analyze and interpret common scientific and technical journals and other related materials
• Experience in management and co-ordination of clinical trials
• In depth understanding of bioimpedance and its applications in the medical market is desirable
• Ability to work independently and balance multiple priorities in a fast-paced FDA regulated environment
• Strong organization and planning skills with an attention to detail and accuracy
• Excellent organizational and problem solving skills
• Ability to effectively present information to top management and/or the scientific community
MIMIMUM EDICAITON, EXPERIENCE OR CERTIFICATIONS:
• Bachelor’s Degree in Science, preferable in (Life Science focus preferred)
• Five (5) years minimum working in clinical affairs, in a life sciences field (medical device preferred)
WORK ENVIRONMENT & PHYSICAL REQUIREMENTS:
• Travel: Position requires business travel (up to 30%), including overnight and international. In addition, this position will require commuting between ImpediMed Bloomington, MN office location and Mayo Clinic, Rochester, MN. Valid driver’s licence and valid passport required for position.
• Physical Demand: Light physical effort. For example, standing, bending or stooping for extended periods, operating office equipment, e.g., personal computer, copier, fax machine; manually handling medium weight materials and/or equipment (0-10 pounds)
• Mental Demand: Moderate to high degree of concentration due to volume, complexity, and/or “pressure” of work
• Full healthcare benefits include: Medical PPO/HMO/HSA choices, Dental PPO, Vision VSP; 401k with matching program for full-time employees once vested in plan.
• Basic Life, AD&D, STD/LTD, EAP Program
ImpediMed is an Equal Opportunity/Affirmative Action Employer