Clinical Research Manager de Kalamazoo, MI em Stryker Corporation

Data de Postagem: 11/19/2019

Resumo do Emprego

Descrição do Emprego

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Clinical Research Manager to join our Instruments Division in Kalamazoo, Michigan supporting Surgical and Neurosurgical business units.

Who we want

  • Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As a Clinical Research Manager, you will manage the planning, execution and interpretation of clinical trials research, data collection activities and clinical operations. You will establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports. You will monitor adherence to protocols and determine study completion while managing clinical and regulatory files and maintain clinical inventory for distribution to investigational sites. You may interact with investigational sites, clinical consultants, Contract Research Organizations and other vendors. You’ll be responsible for ensuring compliance with domestic and international regulatory requirements regarding the conduct of clinical studies (FDA, EU MDR, ISO 14155, ICH_GCP E6).

Responsibilities may include:

  • Ensure execution of Good Clinical Practice (GCP) at all times through provision of training at start-up and initiation meetings for clinical research studies and on-going SOP development
  • Assist with annual clinical affairs strategic planning and budget process
  • Assist with strategy and design of clinical research studies in alignment with marketing, regulatory affairs, and/or research and development objectives
  • Coordinate efficient monitoring of all studies by working with qualified staff, establishing audit procedures and ensuring that clean data are entered into database(s) in a timely fashion
  • Ensure smooth management of the clinical research process by maintaining systems to review and track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management
  • Collaborate with relevant departments such as marketing, research and development, regulatory affairs, compliance, and legal regarding clinical initiatives
  • Provide training materials for relevant departments at study meetings and study launches
  • Monitor outsourced contract research organizations (CROs) in various aspects of management (i.e. budgets, resource allocation) that are relevant to particular project issues
  • Implement training programs for outsourced CROs and other clinical staff that include principles and practices of project management, team communication, protocol and case report form (CRF) writing, electronic data capture (EDC) training and use, adverse event reporting, importance of compliance, budget control and accountability of study devices
  • Prepare white papers for internal use or for customer-facing promotional material to support marketing initiatives
  • Assist with publication strategy and plan in alignment with clinical and marketing initiatives
  • Collaborate with international clinical affairs colleagues to review protocols and/or clinical study updates
  • Assist with review of promotional and/or marketing material to support product launches and market access
  • Assist with review of clinical evaluation reports to support technical files for CE marking
  • Attend and/or contribute to domestic and international clinical meetings as needed

What you need

  • Bachelor’s degree required, focus in Sciences or BSN/RN preferred
  • 5+ years clinical trial experience
  • Hospital environment experience
  • Demonstrated interpersonal communication skills with the ability to communicate across functional areas
  • Excellent analytical and writing skills
  • Strong project management skills – ability to juggle multiple competing priorities
  • Ability to understand and explain detailed regulations and clinical study procedures
  • Ability to make accurate decisions and use good judgement on complex investigations
  • Ability to comply with complex and changing regulations and prioritize work effectively
  • Must be able to observe and correct inconsistencies (clinical study conduct, trend analysis, etc.)
  • Must be able to interpret medical terminology and review/handle sensitive, confidential material (patient data, product information, etc.)

You may also have

  • GCP certification
  • Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA) certification
  • Experience in preclinical research
  • Experience with statistics or statistical models for clinical studies strongly preferred

Work From Home: No

Travel Percentage: 30%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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