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Senior Manager of Clinical Operations, Rare Disease 1204703

Company: Stratacuity: Proven Scientific Placement
Location: Cambridge
Posted on: January 12, 2022

Job Description:

Job Scope & Purpose:Our client is using gene therapy and a cutting-edge platform to treat genetic disease and they are looking for an enthusiastic and highly motivated Associate Director to join their Clinical Operations group. The successful candidate will be responsible for leading clinical trial(s) and a team to make key decisions related to the overall clinical trial execution strategy.Primary Job Responsibilities:

  • Independently leads projects with focus on successful delivery of trials within time, quality, and budget expectations while adhering to strategy and performance against key metrics and corporate goals.
  • Understands the broader industry and uses knowledge of competitive environment to drive efficiency and sense of urgency through trial(s) while maintaining high quality standards
  • Sets the standard for trial management by demonstrating a high level of knowledge of clinical operations methodologies, organizational, project management and leadership capabilities as well as increased strategic insight, decisiveness, and strong judgment
  • Makes certain that there is appropriate identification and ongoing assessment of risks and risk mitigation to ensure integrity of programs and to maintain trial progress
  • Works closely with Clinical Development staff and peers to ensure that study plans are aligned and in support of broader goals and objectives and that there is consistency in approach to management of clinical trial programs
  • Ensures that multiple, novel ideas on how to deliver on clinical trials are generated and considered
  • Builds and implements resource planning and management skills, processes and standards while using an understanding and knowledge of different clinical phase requirements to ensure effective resource management across trials
  • Oversees and manages CRO and multiple vendors including budgets and timelines
  • Ensures outsourced resources, technology and procedures used by external partners, vendors or CROs align with resourcing needs within Clinical Operations
  • Ensures the voice of the patient is represented in the planning, design and conduct of clinical trials
  • Identifies opportunities and leads initiatives to streamline processes and enhance productivity, efficiency and quality of outputs for Clinical OperationsPrimary Job Requirements:
    • Minimum 5-7 years of industry experience.
    • Bachelors Degree in a health related or scientific discipline is required.
    • Minimum 4 years managing clinical studies.
    • Proven track record in resource planning, forecasting, and budgeting.
    • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
    • Rare Disease experience preferred
    • Approximately 15% of this position will require travel.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 PLACEMENTStratacuity 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.by Jobble

Keywords: Stratacuity: Proven Scientific Placement, Cambridge , Senior Manager of Clinical Operations, Rare Disease 1204703, Executive , Cambridge, Massachusetts

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