Clinical Trial Manager
vor 3 Wochen
ABOUT THE ROLE Combining the most advanced and least-invasive rhythm management technologies available with an unwavering commitment to deep collaboration with healthcare professionals, we're helping to reduce costs, improve outcomes and enhance patients' lives.
The Clinical Trial Manager is responsible for the design, planning, execution and leadership of clinical studies and clinical programs worldwide as well as leading cross functional clinical teams in support of the organization's business objectives for product development and/or commercialization.
Possesses a technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within a given therapeutic area.
WHAT WILL YOU BE RESPONSIBLE FOR? Writes study protocols, protocol amendments, informed consents, clinical study project timelines and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice.
Efforts and leadership support product approval, indication expansion and claim support, and mandated post market requirements.Leads the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies.
May lead studies executed by a CRO.Provides clinical input for new product development, post market surveillance, recertification and business development.
Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables.Interacts with regulatory agencies as needed and will use their scientific knowledge in order to provide directives to staff as well as study sites.Facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, Key Opinion Leaders/investigators and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff (BPT/PIB, etc.
).May manage clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines.Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings.
May author scientific abstracts and/or publications.Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc.KEY COMPETENCIES REQUIRED FOR SUCCESS LeadershipActs as a resource and mentor for colleagues with less experience.
May lead projects with manageable risks and resource requirements, often broader, cross-functional projects.
Functional ExpertiseStays up to date in area of expertise and demonstrates use of that knowledge to successfully achieve goals and objectives.
Global PerspectiveUnderstands the position of the organization within a global context and adopts and helps others to adopt a global approach.
Leverages solutions that are scalable, efficient, and cost effective.
Encourages others to share knowledge to ensure success of team, business unit, and organization.
CollaborationWorks effectively with others across the team to achieve goals.
Demonstrates proficient communication and partnership in interactions with others.
Relationship BuildingEstablishes and maintains strong relationships internally and externally.
Contributes to a culture of respect, diversity, and inclusion.
Earns the respect and trust of others through effective interpersonal skills, integrity and authenticity.
Customer FocusIdentifies internal / external customer needs and ensures the effective delivery of high-quality solutions, products and services that meet or exceed customer expectations.
CommunicationCreates an environment which promotes the free flow of communication and information throughout the team.
Communicates effectively in large and small groups.
Openly shares knowledge and expertise.
Listens actively and encourages the open expression of ideas and opinions.
PlanningImplements initiatives and plans that align with individual and team objectives.
Carries out initiatives with clear deliverables, milestones, accountabilities and measures of success.
ExecutionPursues all assignments and projects until completion.
Follows through on assignments to ensure successful completion.
SKILLS AND QUALIFICATIONS 7+ years of related work experience or an equivalent combination of education and work experience.3+ years of experience managing clinical trials.Experience leading clinical trials with investigational devices desired, specifically in the field of electrophysiology or cardiology.
Atrial fibrillation/flutter ablation knowledge is strongly preferred.Strong preference for a professional with a wide range of experience and expertise in a specialized technical field.Ability to apply comprehensive technical knowledge of electrophysiology to resolve complex issues in creative ways.Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships.Experience working with and managing external vendors.Ability to travel across Australia and New Zealand and other countries worldwide.Requisition ID: 591163
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