The Clinical Affairs Manager has a leading role in the planning, coordination and execution of Spirox clinical studies. Studies types range from first-in-man, investigational and post-market studies to evaluate safety, efficacy and performance of medical devices in accordance with global and local regulatory requirements and company policy and procedures. The Clinical Affairs Manager must have excellent verbal and written communication skills, have the ability to motivate and manage teams and have technical clinical research operational skills. The Clinical Affairs Manager must have an excellent working of applicable regulations and guidelines.
The Clinical Affairs Manager, through individual contribution and with the support of his/her team will -
Participate and manage the overall day-to-day operations of multiple clinical studies.
Coordinates and prepares Clinical Investigational Plans and supporting clinical study materials.
Develops and manages clinical study plans and budgets and is responsible for monitoring and achieving targets. Conducts routine and ad hoc meetings and written updates, with clinical affairs, cross-functional teams and company leadership to drive projects and share key information. Manages study budgets and accounting.
Ensures effective and efficient study initiation through procedures and best practices in site qualification and development. Ensures timely trial progress including site management for effective subject recruitment and protocol compliance. Ensures clinical data integrity is maintained through appropriate oversight of staff, sites and monitoring practices through all phases of the studies.
Manages medical monitoring processes, core-labs and other contracted study vendors. Liaises with study committees such as Steering and Data and Safety Monitoring Committees.
Assist in preparation of Clinical Reports for regulatory submissions, including IDEs, PMAs, 510Ks, foreign filings and Clinical Reports for other data dissemination activities.
Develop and maintain working relationships with CROs, contract clinical support staff, and site investigators and staff, including qualification, selection, budget and work-scope negotiations and oversight.
Supports and establishes procedures and work instructions for key clinical research activities to assure compliance and efficient study conduct.
Coordinates and prepares clinical study reports and summaries on clinical trial results for internal review by other departments and senior staff. When appropriate, supports the preparation manuscripts for publication of trial results in refereed journals.
Creates, manages and oversees the maintenance of all trial master files, at company and at investigational sites.
Recruit, lead, manage and develop assigned team to continually improve performance, evaluate strengths and developmental needs; provide appropriate feedback, coaching and mentoring to ensure high levels of performance within the reporting function.
Provide day-to-day guidance and oversight of managers and employees; attract and select a top team, train, supervise, motivate, and develop managers and employees; oversees establishment of effective schedules and workflow; actively work to promote and recognize performance. Be prepared for and manage on-site or remote regulatory audits by company or regulatory agency representatives.
Assign objectives and monitor quality of work; assure management and employees conform to organizational policies and procedures and government regulations.
Keep up to date on overall activities of the team; develop employees; identify problem areas and take corrective actions when needed to address performance or disciplinary issues.
Support company goals and objectives, policies and procedures, performance management programs, and applicable national and local regulations.
Perform other duties as assigned.
Education and Training
BA/BS in life science or equivalent combination of education and experience.
A minimum of 7 years of related experience or equivalent.
Demonstrated ability to successfully manage and execute clinical studies with medical devices to meet business goals using standard best practices and compliance norms. The
Demonstrated ability to supervise CRAs and Monitors, and work successfully on cross-functional teams.
Essential Skills and Abilities
Must be a team builder, team player, and strong leader, with a successful track record.
Demonstrable skills and experience developing Clinical Investigational Plans, launching all aspects of a clinical study and managing multifunctional teams in an efficient, effective and compliant manner.
Exceptional communication skills, oral and written. Strong interpersonal and organizational skills. The ideal candidate will have the personal drive, passion and enthusiasm to understand and successfully navigate within a fast-growing global company striving toward market domination in a rapidly evolving, life-impacting marketplace.
Will demonstrate sound business judgment and the ability to work successfully with all levels of professionals, backgrounds and perspectives, including maintaining confidential and restricted information.
A strong work ethic, self-motivation, and entrepreneurial drive are required, as are high personal values and standards. Honesty, integrity, the ability to work with minimal supervision, a conscientious approach to meeting goals and objectives, and the ability to handle pressure with grace and humor are equally important.
Ability to work independently, using sound judgment, initiative and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
Excellent interpersonal and negotiating skills; ability to solve problems creatively; ability to adapt to changing work priorities; and ability to maintain good working relationships while dealing appropriately with sensitive and confidential matters and with a wide variety of personal and telephone contacts.
Requires above average reading, verbal, and written communications skills; proficiency in business English and grammar; good arithmetic skills and attention to detail to maintain records and process reports.
Conscientious in matters of personal work organization, assistance to managers in organizational processes, detailed record-keeping, and follow up.
Must be able to multi-task, remain calm, and adapt to the ever-changing requirements of a dynamic company.
Proficiency with PC-based office computers, including familiarity with Microsoft Word, Excel, PowerPoint, and Outlook required.
Must be available and willing to work flexible schedules, as needed. Must be able to travel, up to 25%.
Must have the ability to operate an automobile; a good driving record; and a current driver's license, for meetings with clients and other external contacts.
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