Director Clinical Data Sciences
Stryker
Amsterdam, Noord Holland, NL
3 dagen geleden

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting

WHAT YOU WILL DO :

The Director of Clinical Data Sciences, provides the direction of the clinical evidence generation in Trauma & Extremities (T&E) relating to the analytics, statistics expertice, data management, scientific literature access and dissemination, scientific marketing and publication support.

As well as evidence generation from the first surgeries with the product across all business units. Primary focus is to establish / improve major clinical processes that enable the generation of high-quality data in the most efficient manner as possible.

Secondary focus of the role is to through find and implement innovative solutions that drive efficiency, maximize the leverage of clinical data and support publication needs.

Business Process Improvement and problem solving areas of focus would include : All processes utilized by the Biostatistics and Data Management organization related to trial database generation, management, report generation, programming, medical coding to name a few.

Management of all electronic systems, tools, databases, templates utilized for Clinical Operations, Biostats / Data management / Library Service / Early Product Surveillance / Management of Investigator initiated and Collaborative studies etc.

Support the Medical Affairs groups focusing on research supporting past, current and future trials; ensure literature access, ad-hoc analysis, meta analyses, etc.

are conducted robustly yet efficiently. Establishes clinical policies and interprets, executes, and recommends modifications.

Key Areas of Responsibilities :

  • Extensive stakeholder management and alignment, including but not limited to : HCPs, R&D, Marketing, RAQA, PMS, and Clinical Affairs partners, to support transatlantic market access needs
  • Develops and implements Clinical Data Science organizational structure and supervisory relationships with direction and support from Clinical Affairs business unit directors, transatlantic Clinical Operations and Clinical Affairs senior leadership.
  • Ensures strategic alliances with physicians, key opinion leaders, medical societies, patient advocacy groups, consultants and vendors as appropriate to ensure safe, compliant and successful clinical trial conduct.
  • Participates in driving quality awareness in every employee, while guiding the local organization towards improved performance and customer-oriented initiatives.
  • Works with external committees such as Medical Advisory Boards, Steering Committees, Publication Committees, Data Safety Monitoring Boards, Clinical Events Committees and others regarding trial related issues and opportunities.
  • Develops and implements an organized, continuous process for staff development in each level of the organization managed.
  • Responsible for development of realistic clinical data science department budget, schedules, and performance standards and directing the sub-functions for which responsible in accordance with these parameters.
  • Interacts with senior level management concerning significant Clinical matters and clinical support functions to obtain services to support clinical objectives.
  • Conduct briefings and technical meetings for senior management and clinical investigators as needed. Facilitates the sharing of scientific and clinical data across functional resources as required by the business.
  • Analyzes, prepares and presents data from external / internal sources and partners with other
  • Functions such as Clinical Operations, Medical Affairs, Regulatory Affairs and Marketing to obtain regulatory product approvals.
  • Develops and implements an organized, continuous process for staff development in line with departmental guidelines.

  • Guides Clinical employees in support of following clinical trial management processes and procedures. Allocates / re-allocates internal and external technical resources, as needed utilizing in-house resource management tools
  • Contributes to the development of corporate-wide clinical standards for content and quality of clinical trial data and documentation.
  • Participates in internal and external audits as they occur. Reviews and approves corrective action plans at individual sites and across study.
  • Drives policies and processes that incorporate innovative trends and practices in the field of clinical research.
  • Working with the clinical Leadership team, guides and prepares the organization to proactively comply with regulatory agency decisions and changes in regulations.
  • Ensures awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of Stryker.
  • Participates in driving quality awareness in every employee, while guiding the local organization towards improved performance and customer-oriented initiatives.
  • Co-ensures that employees are notified of all mandatory training and quality obligations with HR Manager. Creates training plans and tracks completion of mandatory training.
  • Outreach and collaboration with peers in other Stryker divisions, as well as those inside / outside industry, to further drive innovation, knowledge, and best practices
  • Support the development and implementation of an integrated evidence generation, medical communication, and external stakeholder engagement plan for Stryker's T&E clinical research programs
  • Translate the strategic plan and vision of T&E Clinical Affairs for the generation and delivery of high quality, scientifically robust evidence along the product lifecycle on time and on budget
  • Assess real world data assets and maintain a portfolio of sources, including data licenses, and access to data platforms and tools
  • Responsible to convey proactive and reactive health outcome based information for products in the T&E portfolio to executive decision-makers, external scientific experts, and relevant business influencers to inform access and reimbursement decisions
  • Drive efficiency and automation across the department
  • WHAT YOU WILL NEED :

    Qualifications, Knowledge and Skills

  • Master of Science or equivalent experience in life sciences, medical discipline or related field
  • 15+ years Clinical Sciences and / or Business Program Management experience in the medical industry (device, pharmaceutical, biotechnology).
  • 5+ years in a managerial capacity managing clinical programs and clinical professionals / Program Managers in a cross functional product development setting.
  • Business Process Improvement (BPI) experience strongly preferred.

  • Experience developing and maintaining department Standard Operating Procedures (SOPs)
  • Expert knowledge of governmental regulations, standards, Good Clinical Practices
  • Strong analytical business acumen capabilities.
  • Determined, persistent and excellent influencing skills
  • Demonstrated experience in establishing programs or initiatives that resulted in positive change
  • Excellent collaboration and communication skills; strong cross-functional influencing skills; global teamwork and cultural awareness.
  • Proven track record of engaging, developing and performance managing a team.
  • Excellent communication and influencing skills.
  • Is very customer focused and is service orientated.
  • WHO WE WANT :

  • Sets direction. An innovator who defines ways to create value and deliver on Stryker’s mission and strategic imperatives .
  • Builds organizational capability. A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals.
  • Inspires others. A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride.
  • He / she makes others want to follow, building momentum for action and positively influencing outcomes.

  • Champions talent development. A manager who focuses on maximizing the ability, potential and contributions of themselves and others.
  • Fosters an environment where people can excel through developing, coaching and rewarding performance.

    Know someone at Stryker?

    Be sure to have them submit you as a referral prior to applying for this position.

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