MEDICAL SAFETY MONITOR
The Medical Safety Monitor is responsible for the oversight of study safety including adverse events, protocol deviations and product experiences/complaints reported within a clinical trial. The Medical Safety Monitor ensures the appropriate reporting of the events to the Clinical Department and applicable Regulatory Authorities throughout the life of the trial. The Medical Safety Monitor acts as the liaison between the safety department and all other internal departments as well as to external partners such as CROs, the Clinical Events Committee and the DMC associated to the trial.
- Reviews and analyzes all safety related data for clinical trials including adverse events, protocol deviations and product experiences/complaints.
- Reviews and assist in creating narrative reports for notable clinical events in conjugation with Clinical Events Committee; assisting sites with subject evaluation and protocol adherence; and preparing safety reports to support regulatory notifications and filings.
- Serve as the liaison between the different bodies involved in the safety process i.e. between the CEC, DMC, CRO, Investigators, and Study Team.
- Lead safety work in an outsourced model with different safety responsibilities allocated to multiple organizations
- Support preparation of periodic safety reports to the FDA, IRB/IECs and other competent authorities.
- Prepares presentations to the safety team in order to review and evaluate study safety data.
- Support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other ad hoc reports documents as needed to support formal regulatory filings. Example, PMA.
SKILLS & EXPERIENCE
Bachelor’s degree or equivalent combination of education and experience. Masters, M.D., PH.D., RN, BSN, Nurse Practitioner or Physician Assistant degree (or the equivalent work experience) strongly preferred. Employee must have a strong clinical orientation and knowledge of diverse therapeutic categories. Minimum of 5-7 years of clinical research experience, preferably at least three years in Class III implantable Medical Device Safety.
- Thorough knowledge of 21 CFR, ICH and ISO regulations.
- Regulations/Guidelines governing the reporting of adverse events.
- Experience in participating in safety review processes.
- Strong written and verbal communication skills.
- Familiar with medical terminology and MedDRA.
- Organizational skills & ability to direct and manage projects.
- Ability to manage multiple priorities.
- Analytical, detail-oriented, and with ability to solve problems and multi-task.
- Excel, Word and Power Point proficiency
Candidate with experience in Heart Failure Class III implantable Medical Devices Clinical Studies who have thorough understanding of INR, BUN and Heart Failure are strongly preferred. A familiarity with pacemakers, Implantable Cardioverter-Defibrillator (ICD)/Pacing or stents or an equivalent certification of expertise, and with the clinical trial process is preferred.
Menlo Park, CA
SENIOR MANAGER, GLOBAL THERAPY ADVANCEMENT
The Senior Manager, Global Therapy Advancement possesses a unique combination of therapy advancement, project management, and clinical proficiencies in the cardiac medical device industry: trains implanting and supporting physicians on the use of the Parachute device; proctors live procedures; and educates physicians and allied health professionals on the trial protocol, IFU, data, safety and efficacy of Parachute Therapy (a novel Structural Heart therapy). Plan, develop, and implement policies, procedures, practices, and strategy for achieving comprehensive Sales Training programs for both internal employees and external customers. Establish clinical proficiency goals that will facilitate positive clinical outcomes with CardioKinetix Parachute procedure. This position will be primarily responsible for creating and implementing Training Department programs, as well as, mentoring all new hires until they have completed all required training
This position is responsible for assisting with content development, management and execution of professional education / clinical marketing activities to support clinical trial and product commercialization objectives. Target audience includes global internal “employee” and external “customer” stakeholders. Position responsibilities, accountability and scope include:
- Demonstrate clinical proficiency on all CardioKinetix products.
- Assist in the design/formatting of materials, implementation and management of world class education programs.
- Train employees to drive utilization and study enrollment through cultivating relationships with key investigators: Heart Failure physicians, Electrophysiologists, Echocardiologists, and Interventionalists.
- Help ensure compliance with quality system and standard operating procedure specific to the approval of non-promotional, clinical marketing and scientific materials.
- Identify continuous improvement opportunities to enhance training material approval process efficiency, effectiveness and increase compliance within the quality system and SOP.
- Complete training reports as requested by management, and complete all additional documentation requested by management in a timely basis.
- Evaluate customer (both internal/external) needs and recommend appropriate product training modifications.
- Format/assemble, maintain, and update educational tools and curriculum materials.
- Provides direction and input to all in-house groups such as Clinical Affairs, Regulatory Affairs, Quality Assurance, Operations, IT, Finance, R&D that affect the successful achievement of business objectives.
- Maintain documented case tracking log listing proctor prioritization toward certification with each proctor skills status and projected window of certification completion with parallel development path.
- Collaborate with Clinical/Regulatory Affairs to develop clinically-focused communication tools and guides to increase employee understanding of clinical activity and to aid in effective discussions with physicians.
- Remains aware of all changes that may impact training requirements by seeking out information that may change the clinical process and implementing changes/improvements to training protocols and materials accordingly.
- Manage training process and formal certification process to ensure consistency and quality: training completion verification, track and store training documentation forms, manage continuing education requirements, displayed with reflected records.
- Support internal and external audits.
- Responsible for compliance with applicable Corporate Policies and Procedures
- Performs other related duties and responsibilities, as assigned.
- Support, execute and collaborate with internal clinical parties to include V.P. of Global Therapy Advancement and Director of Clinical Operations.
- Must be able to effectively negotiate internally with other internal groups, and work across functions to support various business initiatives.
- Must help to ensure training materials meet business needs and comply with all regulatory and company requirements.
- Must help influence cultural change to improve compliance within the organization, through continuous education and by working with Quality, Regulatory, Clinical, Engineering, and R&D colleagues in the development of materials and activities to support training.
- Must constantly seek to improve the efficiency and effectiveness of the quality system and standard operating procedure supporting the review and approval process.
- Must be willing/able to travel > 60% of the time.
SKILLS & EXPERIENCE
Minimum of a Bachelor of Science or Arts degree, or equivalent job experience. Advanced degree preferred.
- Minimum of 5-6 years of sales/clinical training in the medical device industry
- Minimum of 2 years of supervisory experience
- Experience with sales training methods and programs
- Strong written and verbal presentation skills
- Strong communication and interpersonal skills
- Knowledge of vascular anatomy & physiology and the Cath lab environment
- Knowledge with the interventional (coronary, endovascular and structural heart) market place
- Awareness of trends and changes in the market, customers and technologies
- Knowledge and experience in training
- Ability to assess and identify individual training needs and design and implement corrective actions
- 5+ years’ experience in clinical field support role on devices requiring assembly or calibration in the field (pacemaker, TAVI, mitral repair etc.)
- Clinical trial implementation experience and knowledge of Good Clinical Practice guidelines
- Comfortable with sterile field practice
- Good physician relationships
- Experience with CT reconstruction
- Capable of reading echo, fluoro and CT
- Mentoring, coaching, or leadership experience
- Well-developed computer skills
Submit your resume at firstname.lastname@example.org for consideration.