Clinical Project Manager 4
Posted on: June 12, 2021
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
- 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
- Prepare and/or critically review project/studyrelated documents
(i.e., protocols, informed consent, site instructions, study
manuals, eCRFs, data review plans, IRB submissions, IDE
- 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.
- Strong track record in managing complex clinical studies and
- Experience in developing and managing academic-industrial
- 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
- 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
- Proven strong interpersonal skills and ability to succeed in a
- 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%.
- Bachelor's degree in a scientific or healthcare related field.
Relevant advanced degree preferred.
- BS with minimum 5 years of experience in study/trial
- MS with minimum 3 years of experience in study/trial
- PhD with minimum 2 years of experience in study/trial
- 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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