Sr./Clinical Project Manager in Lexington, MA at Apex Life Sciences

Date Posted: 10/30/2018

Job Snapshot

Job Description


Senior Clinical Project Manager, 905186

Job Scope & Purpose:

Seeking a qualified and motivated Sr./Clinical Project Manager for our client’s first-in-class, oral, non-absorbed enzyme therapeutic candidates to treat patients with rare and severe metabolic disorders. The CPM/Sr. CPM will play a key role within Clinical Operations in leading clinical study(ies) within timelines and budget scope, and with quality standards. S/he will work closely with cross-functional colleagues and must thrive in a highly entrepreneurial biotech environment.

Primary Job Responsibilities:  

  • Provide operational management of one or more assigned clinical projects with a focus on clinical quality in accordance with FDA, EMEA, GCP, and ICH guidelines and the clinical protocol.
  • Drive progress and operational excellence for clinical trials from planning to close-out, with a focus on adherence to intended timelines and achievement of study deliverables.
  • Guide vendor selection and management.
  • Lead site identification and initiation, and patient recruitment strategies.
  • Lead site training efforts; Plan and present at investigator meetings and vendor meetings.
  • Manage vendor relationship and performance, including CROs and other vendors. Develop good working relationships with study site staff as required. Contribute to data reviews and CSR.
  • Manage the development of the study related documents, including clinical protocol, informed consent forms, study plans, and other study-specific clinical documents.
  • Lead development of eCRF and specifications with data vendor.
  • Lead cross-functional study teams. Lead internal communication of project status.
  • Track and report on the progress of study metrics.

Primary Job Requirements:

  • A BS/MS or higher in biological sciences or related field.
  • Minimum of 5 years of directly related experience is desired. Proven experience in the oversight of the operational aspects of all stages of clinical studies.
  • Progressive experience in the management and conduct of clinical trials (e.g., ICH and regulatory requirements, drug development process, clinical trial material considerations, budgeting and forecasting, trial operational considerations, and clinical compliance). Expertise in monitoring operational functions and working knowledge of data management and cleaning.
  • Late phase clinical trials and global experience preferred.
  • Strong organizational/project management/interpersonal skills.
  • Excellent written, oral/presentation and computer skills.
  • Ability to travel up to 20 % of the time, as needed

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us at info@stratacuity.com or 877-787-2821.

Code: ClinOps

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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