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Clinical Trial Manager

Company: bluebird bio
Location: Cambridge
Posted on: February 25, 2021

Job Description:

Clinical-stage, fast-growing gene therapy company bluebird bio's growing Clinical Development Operations team is setting the standard for trial design, conduct, and analysis in gene therapy across multiple therapeutic areas. Join our collaborative, creative and passionate team as we help bring the promise of gene therapy to patients with severe genetic diseases and cancer. This is not your typical development operations role - come fly with us! Join bluebird bio's enthusiastic and collaborative Clinical Development Operations (CDO) team by contributing to the overall success of our novel gene therapy approach in Sickle Cell Disease (SCD). This position is a key team member who will be responsible for leading clinical trial strategy and execution (CTSE) inspection readiness (IR) activities and working closely with internal and external team members. Additional responsibilities may include study planning and execution, timelines, budget, and vendor management. For the Clinical Trial Manager role, this individual should have strong organizational skills, strong knowledge of FDA Regulations and GCP/ICH guidelines. You will ensure trial(s) are managed to the highest quality to ensure safety and effectiveness of bluebird bio's products.-- About the role:

  • Leads, defines, implements, and manages solutions to IR issues in collaboration with CRO partners and cross functional stakeholders. Works closely with the Proactive Clinical Excellence (PACE) team on identified risks/issues.
  • Acts as the subject matter expert and primary point of contact for relevant functional stakeholders on IR activities and deliverables to provide real-time, proactive advice and guidance to drive towards inspection readiness.
  • In partnership with the clinical study team, ensures trial compliance is in accordance with regulations, SOPs, and processes. Special focus on vendor management, risk management, and documentation of study team training.
  • Reviews the electronic trial master file (eTMF) and works with CRO and functional area representatives to ensure an inspection ready eTMF. Works closely with PACE to resolve any systematic issues.
  • Liaises with PACE to contribute to opportunities to further develop and improve GCP Inspection and compliance strategy, processes, tools, and templates. Escalates when identified gaps may impact inspection readiness.
  • Leads/owns formal risk assessment activities; review and approve corrective action plans across study, participate in internal/external study related audits.
  • May perform study site activities, such as on-site or remote monitoring, co-monitoring, training, and motivational visits, as needed.
  • Review of study specific data, including tables, listings, and figures.
  • Participate in departmental initiatives such as the development and review of SOPs, Work Instructions and Administrative References. About you:
    • BS/BA degree required and/or minimum 8 years clinical research experience with experience gained with a CRO, biotech, or pharmaceutical company
    • Experience in supporting Regulatory Authority (e.g. FDA, EMA, MHRA) GCP inspections is required
    • Ability to work, lead, coordinate, and project manage activities to drive change within the organization
    • Pragmatic and solutions oriented
    • Working knowledge of clinical trial management activities in an outsourced CRO model
    • Experience with supporting clinical site and/or vendor audits, development of CAPAs and monitoring their implementation to successful resolution
    • Ability to management multiple projects simultaneously, prioritize workload for teams and function in fast-paced environment
    • Ability to follow and implement directives, meet deliverable timelines, exercise managerial discretion, advanced analytical/forward thinking and prioritization skills, and escalates when necessary
    • Experience with eTMF and Quality Management Systems - - Veeva experience preferred
    • Positive, outgoing, and collaborative attitude with a passion for helping patients using innovative science
    • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself Will you now or in the future require bluebird bio to commence ("sponsor") an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)? --*
      Point of Data Transfer - GDPR --*
      Your privacy is important to us. bluebird bio, Inc. will use the information provided on this form to evaluate you for the position you are applying for and stay in contact with you for recruiting and hiring purposes. Please take a moment to read the Data Privacy Consent --located here and provide consent to the collection, processing, and notification of your rights regarding your personal information below. For more general information on how we will use, store, and protect the personal information provided through this form and on the website, please read our privacy policy located--here .Read the Data Privacy Consent and select "I accept" to agree to the collection and processing of your personal information. U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at bluebird bio are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Are you Hispanic/Latino? Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
      • Autism
      • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
      • Blind or low vision
      • Cancer
      • Cardiovascular or heart disease
      • Celiac disease
      • Cerebral palsy
      • Deaf or hard of hearing
      • Depression or anxiety
      • Diabetes
      • Epilepsy
      • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
      • Intellectual disability
      • Missing limbs or partially missing limbs
      • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
      • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: bluebird bio, Cambridge , Clinical Trial Manager, Executive , Cambridge, Massachusetts

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