Clinical Project Manager in Cambridge, MA US at Apex Systems

Company: Apex Systems Inc.
Location: Cambridge
Posted on: April 5, 2021

Job Description:

Clinical Project Manager in Cambridge, MA US at Apex Systems Are you a motivated Clinical Project Manager looking to make an impact in a smaller environment with exceptional leadership? Our client is a clinical-stage biopharmaceutical company is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer, infectious diseases and autoimmune diseases. This is an excellent opportunity for someone with strong organizational skills and the ability to work on a variety of tasks and projects simultaneously with minimal supervision. The company culture is fast-paced and committed to scientific excellence, innovation, and teamwork. Primary Job Responsibilities:

• Manage and lead the oversight of CRO activities and other clinical vendors to ensure quality standards for clinical studies are met.
• Work with the clinical team to support design, development, execution, and delivery of the clinical study in accordance with the clinical development plan/strategy and timelines.
• Collaborate closely with the Sr. Director of Clinical Operations, working on execution and oversight of clinical trials.
• Review CRO progress reports and assist in the tracking and reconciliation of clinical data, sample collection, and lab results.
• Provide guidance to study monitors and investigative study sites to ensure consistency in interpretation of the protocol and study procedures.--
• Plan and lead study related meetings and maintain a decision and action-items log.
• Manage multiple vendors (e.g., central labs, specialty labs) to ensure quality standards and timelines are achieved.
• Review site monitoring reports and follow-up letters and collaborate with onsite quality audits.
• Be responsible for oversight and maintenance of Central Files (eTMF), including ensuring files are inspection-ready for filings. Primary Job Requirements:
  • Bachelor's degree with a minimum of 4+ years of clinical research experience in the biotechnology/biopharmaceutical industry, including at least 2 years of study management experience.
  • Experience with oncology studies preferred.
  • Working knowledge of FDA regulations and ICH GCP guidelines.
  • Experience in clinical operations and development, including all stages of study conduct (start-up, maintenance and close-out).
  • Experience working with Clinical teams to initiate and assist in writing protocols, ICFs, and other key clinical documents.
  • Experience in study management, including management of CROs and other vendors, with minimal supervision.
  • Exceptional attention to detail and excellent organizational skills with a desire to roll up one's sleeves.
  • Excellent oral and written communication skills.
  • Ability to prioritize duties and manage multiple matters from start to finish with minimal supervision with a demonstrated ability to lead change and make independent decisions.
  • Ability to effectively and positively work with executive-level management. 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. Code: ClinOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 employeeservices@apexsystemsinc.com or 844-463-6178. Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 employeeservices@apexsystems.com (Do not submit resumes or solicit consultants to this email address) or 844-463-6178. Join our Talent Network!

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