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Clinical Project Manager 4

Company: Hologic
Location: Newark
Posted on: June 12, 2021

Job Description:

Job Summary

As a key member of the Breast and Skeletal Health Clinical Affairs team, the incumbent will be responsible to oversee and execute major US-based and global clinical trials across multiple phases of product development - ensuring on-time, on-budget, and high-quality execution and conduct. Working alongside a high performing team of clinical development and clinical operations experts, the incumbent will support multiple medical device franchises via the generation of evidence in support of efficacious breast and skeletal health technologies. Strong collaboration across the global regions and with functional departments such a Clinical Development, R&D, Program Management, Regulatory Affairs, Legal, Marketing, Service and Operations will be necessary for success in this role.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Experienced Clinical Project/Program Manager with independently, passionately, and effectively driving the planning and execution of clinical studies from study start to closure.
  • Lead the creation, management, and execution of advanced clinical programs in support of product development and evidence generation activities.
  • Deliver high-quality studies, on-time and on-budget, in compliance with all applicable domestic and international regulations and standards (GCP and ICH).
  • Build a high performing clinical operations framework through skillful management and expansion of talent.
  • Jointly partner with Clinical Development to ensure the appropriate design and reporting of clinical studies.
  • Participate in the creation and maintenance of relevant Standard Operating Procedures governing the conduct of clinical operations activities.
  • Prepare and/or critically review project/studyrelated documents (i.e., protocols, informed consent, site instructions, study manuals, eCRFs, data review plans, IRB submissions, IDE applications, etc.).
  • In collaboration with the Clinical Development team, select and manage CROs and other consultants/vendors, including contract/budget negotiation, and overseeing CRO activities beginning from CRO award through trial closeout.
  • Contribute subject matter expertise in cross-functional strategy and tactical discussions aimed at identifying the most impactful and efficient study designs.
  • Participate in the preparation of regulatory filings and interactions with regulatory bodies, as needed. Prepare and manage relevant clinical documentation in support of product files (e.g. MDR Clinical Evaluation Reports).
  • Maintain company records related to Breast and Skeletal Health division research on appropriate domestic and international databases (e.g., ClinicalTrials.gov).
  • Maintain records of and lead divisional efforts in the annual reporting of Sunshine Act payments.
  • Ensure high-quality documentation is properly catalogued in quality management systems.

Qualifications

  • Strong track record in managing complex clinical studies and trials.
  • Experience in developing and managing academic-industrial partnerships.
  • Clinical or research experience in breast cancer screening, diagnostics and treatment domains.
  • Firm understanding of regulatory issues in the medical device space and GCP.
  • Knowledge and understanding of medical and clinical terminology, clinical workflow, trial design, and levels of evidence.
  • Excellent oral and written communications skills as well as presentation skills and the ability to effectively communicate Hologic's position to various stakeholders to achieve operational alignment.
  • Proven strong interpersonal skills and ability to succeed in a matrixed environment.
  • Attention to detail and ability to meet deadlines.
  • Strong organizational skills with the ability to multi-task and adjust to changing priorities.
  • Demonstrated ability to think strategically, set and manage priorities, manage multiple projects and allocate and reallocate resources and effort as required.
  • Collaborative mindset to achieve common goals.
  • Ability to travel up to 25%.

Education

  • Bachelor's degree in a scientific or healthcare related field. Relevant advanced degree preferred.

Experience

  • BS with minimum 5 years of experience in study/trial management.
  • MS with minimum 3 years of experience in study/trial management.
  • PhD with minimum 2 years of experience in study/trial management.
  • Experience working for a sponsor or CRO in the medical device or pharmaceutical industry.
  • Medical device industry experience strongly desired.

Agency and Third-Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

Keywords: Hologic, Newark , Clinical Project Manager 4, Other , Newark, Delaware

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