Clinical Trial Manager

2 weeks ago

Stanford, United States Ascendis Pharma Full time

Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncology. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We are a dynamic workplace for employees to grow and develop their skills. Responsibilities: Plan, drive and coordinate operational aspects of clinical trial execution from initiation, planning, execution, maintenance and close-out Ensure clinical trials are executed according to external regulations and internal procedures If Global CTM, accountable for meeting corporate and departmental goals related to a clinical trial; delegate specific activities to Regional CTMs, as appropriate Main tasks: Work with the Clinical Science team to review and clean data Manage the logistics for the Safety Review Committee (SRC) Participate in internal clinical trial team meetings Give input to clinical trial protocols in collaboration with the GCPL, Medical Expert or Clinical Scientist. Participate in identification, assessment and selection of relevant CROs and vendors; for example, central and special laboratories and imaging service providers. Participate in identification, qualification, initiation and close-out of clinical trial sites. Author, give input to or review trial plans, such as Project Management Plan, Enrolment Plan, Monitoring Plan, Protocol Deviation Plan, etc. Provide input to patient information/consent, eCRF forms and completion guidelines, site instructions for specimen collections, study drug order forms, etc. Manage and oversee contracted CROs and vendors; identify potential risks and resolve issues with CROs; establish vendor management plans and review quality metrics. Plan Monitor and Investigator Meetings and other training related activities for sites and vendors, as needed Review protocol deviations and data listings. Support IRB/IEC and regulatory submissions, as needed. Communicate directly with trial site staff and investigators to support the relationship between the sponsor and site; including co-monitoring visits. Review and approve vendor invoices. Perform periodic review of the electronic Trial Master File (eTMF) Support safety reporting. Maintain and report metrics for trial tracking and clinical site performance, including patient recruitment and retention. Contribute to Ascendis' clinical Quality Management System by authoring or contributing to clinical SOPs. Work with CROs to prepare sites for clinical audits and to respond to audit findings conducted by Clinical QA and external regulatory agencies Contribute to clinical study reports, protocol amendments, data analysis review and study strategic development when needed Prepare for and participate in regulatory inspections Perform monitoring oversight visits (onsite or remote) Attend site visits (PSSVs, SIVs, motivational) as needed Requirements BSc or MSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent) Minimum 3 years of experience within clinical operations or related function Experience with one or more phases in clinical trial conduct; setup, maintenance and closure Some understanding of one or more adjacent key functions, including medical, biometrics, regulatory and clinical trial supplies General understanding of the drug development process Ability to communicate with individuals in a respectful way Decision making abilities, but knows when to ask for advice Structured, organized and a proactive problem-solver, striking the right balance between detail and progress Good writing, communication and presentation skills Experience working in global/virtual teams Salary $60-75/hour Benefits Medical insurance Vision insurance Dental insurance 401(k) Paid maternity leave Paid paternity leave Commuter benefits Disability insurance

  • Senior Manager, Clinical Trial Supplies, Oncology

    3 weeks ago

    Stanford, United States Ascendis Pharma Full time

    Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncology. Guided by our core values of patients, science, and...

  • Clinical Research Manager

    2 weeks ago

    Stanford, United States Stanford University Full time

    Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of st Clinical Research, Clinical, Research, Manager, Leadership, Healthcare

  • Sr. Cancer Clinical Research Manager

    2 weeks ago

    Stanford, United States Stanford University Full time

    Senior Clinical Research Manager - Blood and Marrow Transplantation (BMT) (Hybrid) The Stanford Cancer Institute's Clinical Trials Office (SCI-CTO) is the centralized organization for cancer clinical research operations at Stanford Medicine. The SCI- Clinical Research, Clinical, Cancer, Manager, Research, Operations Manager, Healthcare

  • Clinical Research Coordinator 2

    4 weeks ago

    Stanford, United States Stanford University Full time

    Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee data management for research projects. Develop and Clinical Research, Research Coordinator, Clinical, Research, Coordinator, Leadership, Healthcare

  • Clinical Research Coordinator 2

    4 weeks ago

    Stanford, United States Stanford University Full time

    Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee data management for research projects. Develop and Clinical Research, Research Coordinator, Clinical, Research Associate, Coordinator, Research, Healthcare

  • Cancer Clinical Research Coordinator Associate –

    5 days ago

    Stanford, United States Stanford University Full time

    Cancer Clinical Research Coordinator Associate – Radiation Oncology (Hybrid)The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works...

  • Cancer Clinical Research Coordinator Associate –

    5 days ago

    Stanford, United States Stanford University Full time

    DetailsPosted: 03-Dec-23Location: Stanford, CaliforniaType: Full-timeSalary: OpenCategories:Staff/AdministrativeInternal Number: 101602Cancer Clinical Research Coordinator Associate – Radiation Oncology (Hybrid)The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country,...

  • Assistant Clinical Research Coordinator

    6 days ago

    Stanford, United States Stanford University Full time

    Stanford University's Autism and Developmental Disorders Research Program (ADDRP) and Clinical Neuroscience (CNS) Lab in the Department of Psychiatry and Behavioral Sciences are seeking an Assistant Clinical Research Coordinator to perform administrative support duties related to the collection and analysis of MRI and clinical data and the coordination of...

  • Department Clinical Research Manager

    4 weeks ago

    Stanford, United States Stanford University Full time

    Strategic Management and Coordination of Clinical Research Projects: assist in start-up of clinical research projects, track project progress, assist in logistical aspects and interface with university resources. Hire, orient, train, and conduct perf Clinical Research, Clinical, Manager, Research, Clinic, Department, Healthcare

  • Clinical Research Coordinator 2 Hybrid

    4 days ago

    Stanford, United States Stanford University Full time

    The Department of Neurology at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.Duties include• :Oversee subject...

  • Clinical Research Coordinator 2 Hybrid

    6 days ago

    Stanford, United States Stanford University Full time

    The Department of Neurology at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.Duties include• :Oversee subject...

  • Senior Research Coordinator in Precision Psychiatry and Neuroimaging

    3 weeks ago

    Stanford, United States Stanford University Full time

    Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee data management for research projects. Develop and Research Coordinator, Clinical Research, Imaging, Psychiatry, Precision, Neuro, Healthcare

  • Clinical Event Committee Specialist II

    5 days ago

    Stanford, United States Stanford University Full time

    The Stanford Center for Clinical Research (SCCR) is a growing academic research organization within the Stanford Department of Medicine. Our mission is to conduct and promote high-impact, innovative clinical research to improve human health.SCCR seeks a mission-driven Clinical Event Committee Specialist. You will work with a high-performing team of clinical...

  • Academic Research Scientist in Neuroscience and Precision Mental Health

    5 days ago

    Stanford, United States InsideHigherEd Full time

    Academic Research Scientist in Neuroscience and Precision Mental Health (5 Years Fixed Term) School of Medicine, Stanford, California, United States Academic May 14, 2024 Post Date 103254 Requisition #The Stanford Center for Precision Mental Health and Wellness within the Department of Psychiatry and Behavioral Sciences at Stanford...

  • Academic Research Scientist in Neuroscience and Precision Mental Health

    6 days ago

    Stanford, United States InsideHigherEd Full time

    Academic Research Scientist in Neuroscience and Precision Mental Health (5 Years Fixed Term) School of Medicine, Stanford, California, United States Academic May 14, 2024 Post Date 103254 Requisition #The Stanford Center for Precision Mental Health and Wellness within the Department of Psychiatry and Behavioral Sciences at Stanford...

  • Physical Therapist

    5 days ago

    Stanford, United States MORE Physical Therapy, Inc. Full time

    Job DescriptionJob DescriptionBenefits:401(k)Health insuranceSigning bonus At MORE Physical Therapy, Inc. our passion is empowering patients to return to play, return to work and return to life! We currently have opportunities for a full time Assistant Clinical Manager in our San Jose (Rosegarden) and Stanford clinics.BENEFITS:We provide competitive...

  • Cancer Clinical Research Data Manager Sarcoma Oncology

    1 week ago

    Stanford, United States Stanford University Full time

    This Cancer Clinical Research Data Manager position will be home based from anywhere within the United States. - - Cancer Clinical Research Data Manager (Data Aide 3) -SARCOMA ONCOLOGY (Remote) The Stanford Cancer Institute (SCI) is one of an elite n Clinical Research, Manager, Clinical, Oncology, Research, Cancer, Healthcare

  • Assistant Clinical Research Coordinator

    5 days ago

    Stanford, United States Stanford University Full time

    Stanford University is seeking an Assistant Clinical Research Coordinator to perform administrative support duties related to the collection of clinical data and/or the coordination of clinical studies. Work under supervision of the principal investigator and/or study coordinator/supervisor. Duties include:Schedule and/or call subjects for appointments;...

  • Sleep Assistant Research Coordinator

    5 days ago

    Stanford, United States Stanford University Full time

    The Computational Psychiatry, Neuroimaging and Sleep Laboratory (CoPsyN Sleep Lab) is currently recruiting for a motivated and compassionate Sleep Assistant Research Coordinator for projects investigating the relationships between sleep disturbances, brain function, and emotional well-being. The CoPsyN Sleep lab is focused on translational clinical research...

  • Clinical Research Coordinator 2

    3 weeks ago

    Stanford, United States Stanford University Full time

    The Department of Neurology at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects o Clinical Research, Research Coordinator, Clinical, Research, Coordinator, Leadership, Healthcare