Do you have the proven ability to manage and meet all objectives for key clinical studies? Are you passionate about independently developing clinical study protocols and executing on key clinical studies?
If your answer is yes, then we may be looking for you!
Spectranetics, recently named one of the “Most Trusted Companies”, has an opening for a Clinical Project Manager.
What You Will Do: You will be responsible for managing and meeting the objectives of key clinical studies, satisfying all applicable regulatory standards and company requirements. You will be independently developing clinical study protocols and executing teh clinical studies/trials including management of direct reports.
What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with a great team of dedicated experts and leaders in the Medical Device Industry who will support your continued growth. You will learn from your fellow teammates, Clinicians, Sales Leaders, and other industry professionals about our state of the art products.
What You Will Become: You will become influential in the ongoing management of the Company's Clinical program. You will provide expertise, discipline, problem solving, collaboration and dedication to become a master of industry-leading best practices.
What Success Looks Like:
Manage applicable staff and programs within a therapeutic area of VI
Recruit staff members, conduct performance appraisals, and fulfill other managerial responsibilities as required
Provide direction, subject matter expertise, training materials, and mentoring to the Clinical Affairs team to support corporate and departmental objectives and the building of high performing teams
Acts as Project Leader and/or core team leader of key clinical trial (s) and assures successful conduct of assigned clinical programs consistent with R&D and Marketing plans and applicable regulations/policies. This may include interfacing with representatives from key functional groups including: Clinical Affairs, Quality, Monitoring, Manufacturing, Sales, Marketing, Customer Service, Finance, Regulatory Affairs, R&D, and U.S. Clinical Groups.
Provides input on development of study plans, objectives and trial needs assessment
Works with Clinical management to develop study objectives, strategy, scope and schedule in order to meet trial needs.
Manages development of investigational protocol in consultation with the cross-functional project team, investigators and the clinical team.
Manages selection of Principal Investigators and clinical sites.
Interfaces with, and ensures training of investigators, site staff and Clinical Affairs staff.
Ensures the development, review and approval of case report forms (CRFs) for the clinical study.
Provides guidance to the Clinical Study Team in development of study materials such as patient brochures, patient recruitment materials, Manual of Operations, and Newsletters as required for the study.
Interfaces with regulatory agencies as required.
Manages set-up and execution of Data Safety Management Board and/or Clinical Events Committees as it relates to project activity.
Manages the selection of CRO(s) and core laboratories.
Manages outside CRO(s) associated with a trial to ensure project deliverables are completed
Adheres to contract, deliverables, data collection/management and other trial associated activities.
Provides direction and oversees all core laboratories associated with a trial to ensure integrity and quality of data collection.
Provides input and support for post-clinical activities and market launch of products.
Works with Clinical Study Team to ensure that all necessary information for post study reports and publications are provided, as applicable. Coordinate with cross-functional leaders to provide input on clinical study activities
Develops and maintains strong working relationships with clinical trial investigators including National Principal Investigators (NPI) providing input into clinical trial design, execution and publication planning.
Develops and maintains strong working relationships with the Clinical Study Team ensuring that the progress and status of the clinical trials is effectively discussed and communicated, and also providing leadership and serving as a role model
Manages investigator conferences and provides updates on clinical study status. Ensure clinical research projects are conducted in accordance with company standard operating procedures (SOPs/DOPs), Good Clinical Practice (GCP), and specific country regulations, as applicable
Ensures appropriate resources are maintained for the various projects assigned to their area
Support regulatory agency audits
Bachelor's degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field.
Masters degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience.
Minimum 4-7 years experience directly supporting clinical research or similar experience in a medical/scientific area.
Experience with mentoring others preferred.
Direct report experience required. Ability to work effectively with cross functional teams.
High attention to detail and accuracy.
Advanced written and oral communications skills.
Able to manage multiple tasks independently
Able to identify problems, develop solutions and implement to address study issues
Proficient knowledge of medical terminology, disease states and current treatment modalities
Expertise with GCPs and regulatory compliance guidelines for clinical
Knowledge of clinical and outcomes research study design, methods and statistics.
Special Requirements: May require up to 40% travel - must be flexible with travel to meet needs of the study
Material and Equipment Directly Used:
Knowledge of and skill in using Microsoft Office, specifically, Word, Excel, PowerPoint, Project and Outlook.
Spectranetics' Policies and Procedures
FDA regulations and international standards
Computers and software, Microsoft Outlook, Microsoft Office, Concur, Oracle, and other Custom Software, office phones, fax and copy equipment as well as other office equipment as required.
Agencies that submit a resume to SPNC must have a current executed SPNC Agency Agreement executed by a member of the Talent Acquisitions Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a SPNC Recruiter. All resumes must be submitted to the vendor portal under these terms or they will not be considered.
This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.
All applicants must pass a pre-employment drug screen to be hired.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or status as an individual with a disability.