Manager, Clinical Affairs Operations, Hematology/IVD Diagnostics

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Santa Clara, CA
Job Type
Direct Hire
Sep 11, 2018
Job ID
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Clinical Affairs leadership positon within the Diagnostics Hematology business unit. Responsible for global clinical studies for Hematology IVD products. Lead resources within Hematology and partner clinical sites globally to achieve clinical objectives. Lead a team of approximately 4 in clinical affairs. Reports to the Director, Clinical Affairs for Hematology. The Manager has business unit-wide influence, responsibility and functions as an internal expert resource. The individual will be actively called upon to provide clinical affairs guidance to business unit leadership and project teams.
  • Lead design, planning, development and monitoring of clinical projects and trials in support of the business strategy
  • Take a lead role in the development of the clinical strategy and design by defining the clinical plan by establishing the appropriate clinical protocol for the desired product claim
  • Lead resources to ensure successful execution of clinical studies.
  • Directly visit and own clinical sites as part of global studies. Role will travel globally 20%. 
  • Generate clinically/scientifically sound statistically analyzed data to confirm performance claims supporting regulatory submissions and to ensure that the product conforms to defined user needs and/or requirements
  • Select and build relationships with clinical sites
  • Review and draft the clinical studies sections for regulatory submissions to ensure adequacy of support for all claims pertaining to safety, efficacy, clinical performance and Independent Review Board. 
  • Represent clinical affairs during post-market surveillance and to regulatory agencies as part of the pre-market product development process.
  • Develop and advance the organization’s policy and procedures for clinical affairs and compliance to establish a compliant culture
  • Coach, develop and motivate the team to build a sustainable pipeline of leaders for the organization. Act as a model leader in the organization.
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Manage staff (i.e. clinical operations specialists) to ensure efficient execution of clinical research activities
  • Manage clinical operations activities in support of clinical study timelines and in accordance with applicable regulations; GCP; and ADD policies and procedures.
  • Supports clinical research team with review and monitoring of clinical study data as needed.
  • Manage development and tracking of Clinical Research Process Metrics to facilitate continuous improvement.
  • Manage tracking and reporting of Clinical Research activities for Sunshine Act reporting.
  • Provide leadership; direction and accountability for clinical research process improvement projects.
  • Verify that changes related to process improvements have been established through objective evidence review of metrics; documents or other clinical research related data.
  • Provide leadership; direction and accountability for new technology projects for the Clinical Research organization.
  • Provide input into the strategic plan and long range plan for the Clinical Affairs organization; as needed.
  • Effectively communicate; through the planning and execution of meetings and presentations; project goals; milestones and updates; to senior management and other functional areas; and regulatory authorities.
  • Maintain a professional; product; and market expertise via independent reading; networking and training.
  • Interview job candidates and hire staff. Manage the orientation and training for new staff members. Prepare and conduct performance evaluations.
  • Actively participate in establishing best practices through strategic planning; training and writing/editing appropriate documentation.
  • Manage department expenses within budget.
  • Accountable for achievement of both financial and performance goals for projects and overall area of responsibility. Responsible for mentoring direct reports and providing guidance with their career development. Remove barriers impeding the progress of projects and programs. Recommend actions and develop responses to cope with changing requirements and regulations. Anticipate future direction and participate in conflict resolution at the management level.
 Minimum Qualifications
  • B.S. in Biological Science or Medical Specialty (e.g. RN) required. Master's degree or higher is desired. Clinical Laboratory Certification MT (ASCP); Certified Clinical Research Associate (CCRA); preferred
  • Knowledge of regulations and standards (GCP) affecting IVDs and Biologics required.
  • 9 years’ experience in a clinical research environment or a research laboratory with automated IVD assay/instrument experience.
  • Demonstrated leadership and global experience required.
  • Management experience with budgetary responsibility is preferred.
 Preferred Qualifications
  • 10 years’ experience in Medical Device Class II industry Clinical Affairs. Hematology IVD experience is preferred.
  • Track record of leadership of clinical studies. Has directly lead global clinical study used in FDA 510k & submission & CE declaration for new system launch.
  • Expertise in clinical data review and statistical analysis following CLSI guidelines
  • 5 years’ direct people management experience
  • Bachelor’s degree. Advanced technical education preferred
Identifier: $MEDD