We have other current jobs related to this field that you can find below
-
Sr Clinical Trial Manager
2 months ago
Menlo Park, United States Summit Therapeutics Sub, Inc. Full timeJob DescriptionJob DescriptionOur Mission:To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration...
-
Sr. Clinical Trial Associate
2 weeks ago
Menlo Park, United States Summit Therapeutics Sub, Inc. Full timeJob DescriptionJob DescriptionOverview of Role:The CTA/Sr. CTA is responsible for supporting the daily workflow of clinical operations activities. The CTA/Sr. CTA provides administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting...
-
Clinical Trial Assistant
1 week ago
Overland Park, Kansas, United States IQVIA Full timeJob Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...
-
Associate Director Clinical Operations
1 week ago
Menlo Park, United States The Steely Group Full timeM-F standard hours with OT - this is a true startupOnsite in Menlo Park, CAAssociate Director/Director, Clinical OperationsJob OverviewWe are looking for a talented and highly motivated Clinical Operations professional to join our client's fast-paced biotech startup. Under the direction of the Executive Director, Clinical Operations, this role will support...
-
Senior Trial Paralegal
2 weeks ago
Overland Park, United States People People Full timeJob DescriptionJob DescriptionErise IP, a mid-sized law firm, is on a mission to find an experienced and professional Senior Trial Paralegal to join our growing, collaborative team. This position is located in Overland Park, Kansas and is an in-person position given the nature of the work to be accomplished.If you have previous mid-sized or large firm...
-
Senior Manager, Clinical Data Management
15 hours ago
Menlo Park, United States Summit Therapeutics Sub, Inc. Full timeJob DescriptionJob DescriptionOverview of Role:Summit is seeking an experienced, detail-oriented Sr. Manager of Clinical Data Management with a strong background in oncology clinical trials. This role will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeliness of clinical data across multiple oncology...
-
Overland Park, United States Walgreens Full timeJob Description Job Summary The Manager, Clinical Site Operations reports to the Director, Clinical Site Operations, and functions as the direct manager for patient-facing site staff supporting assigned studies. This role supervises clinical trial activities, the implementation of and adherence to study protocols, and oversees the schedules of...
-
Associate Manager, Pharmacovigilance
3 weeks ago
Florham Park, United States Clinical Resource Network (CRN) Full timeOur client is looking for a Associate Manager, Pharmacovigilance for a Hybrid position in the Livingston, NJ area.Responsibilities:Responsible for full oversight of individual case safety reports (ICSRs) and aggregate safety reports for company product portfolio.Manage review of individual case safety reports to ensure timely processing of adverse event...
-
Sr. Manager, Statistical Programming
5 days ago
Menlo Park, United States Summit Therapeutics Sub, Inc. Full timeJob DescriptionJob DescriptionOverview of Role:The Senior Manager, Statistical Programming will be responsible for leading and managing the statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, with a primary focus on oncology studies. This role will oversee the development and implementation of...
-
Associate Director
1 month ago
Menlo Park, United States Proclinical Staffing Full timeAssociate Director of Formulation Development - Permanent - Menlo Park CAProclinical is seeking a dedicated and innovative individual for the role of Associate Director, Formulation. Primary Responsibilities:The successful candidate will play a crucial role in supporting drug product development and manufacturing of solid oral dosage forms at contract...
-
Trial Attorney
2 weeks ago
Pinellas Park, United States State Farm Full timeJob DescriptionOverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths...
-
Senior Manager, Project Management
1 month ago
Menlo Park, United States Summit Therapeutics Sub, Inc. Full timeJob DescriptionJob DescriptionOur Mission:To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to:...
-
Trial Attorney
2 weeks ago
Pinellas Park, United States State Farm Full timeOverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...
-
Trial Attorney
2 weeks ago
Pinellas Park, FL, United States State Farm Full timeOverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...
-
Director Statistical Programming
1 month ago
Menlo Park, United States Summit Therapeutics Sub, Inc. Full timeJob DescriptionJob DescriptionOur Mission: To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration...
-
Menlo Park, United States Chantibody Therapeutics Inc. Full timeChantibody Therapeutics Inc. is a biotech company based in Menlo Park, California that focuses on the discovery and development of transformational therapeutics for unmet medical needs when combating life-threatening diseases, especially cancer. We’ve developed a proprietary AI-guided antibody discovery platform as a solid foundation for innovative...
-
Menlo Park, United States Chantibody Therapeutics Inc. Full timeChantibody Therapeutics Inc. is a biotech company based in Menlo Park, California that focuses on the discovery and development of transformational therapeutics for unmet medical needs when combating life-threatening diseases, especially cancer. We’ve developed a proprietary AI-guided antibody discovery platform as a solid foundation for innovative...
-
Clinical Lab Scientist
3 months ago
Menlo Park, United States Randstad Life Sciences Full timeJob DescriptionJob DescriptionClinical Lab Associate9-month assignment (can extend or possibly become FTE)Menlo Park, CA - 100% on-siteShift informationShift will be 3 PM -11:30 PM (potential for this to possibly change to 1 PM - 8:30 PM)1st month of training will be during AM shift (7:30 AM - 4 PM) - non negotiableOnce a month, will need to support weekend...
-
Senior or Staff Manufacturing Engineer
2 months ago
Menlo Park, United States Cambridge Executive Recruiters Inc. Full timeSTART-UP COMPANY INFO:Well-Funded Class III Cardiovascular medical device startup, 35 peopleLocation: Menlo Park, CAFlagship device is a Catheter-based device with novel technology for vascular access and stabilization in-situ.Device Status: FIH soon; with IDE Trial starting later this fall.35MM Round B Funding in place from Strategic & VC Investors.Position...
-
Senior or Staff Manufacturing Engineer
2 months ago
Menlo Park, United States Cambridge Executive Recruiters Inc. Full timeSTART-UP COMPANY INFO:Well-Funded Class III Cardiovascular medical device startup, 35 peopleLocation: Menlo Park, CAFlagship device is a Catheter-based device with novel technology for vascular access and stabilization in-situ.Device Status: FIH soon; with IDE Trial starting later this fall.35MM Round B Funding in place from Strategic & VC Investors.Position...
Senior Clinical Trial Associate
2 months ago
Job Title: Senior Clinical Trial Associate
Department: Clinical Operations
Our Mission:
To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.
We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We plan to initiate phase-III clinical studies in the following NSCLC indications:
Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)
Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)
Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.
Overview of Role:
The CTA is responsible for supporting the daily workflow of clinical operations activities. The CTA provides administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the study-specific eTMF.
Role and Responsibilities:
Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies
Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking
Responsible for ensuring study documentation (including trial master files (TMF), study related contracts and financial level documentation) and study documentation is processed, maintained/archived in compliance with ICH-GCP, Company policy and procedures.
Be responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File (TMF)
Manage the clinical study creation and set-up for the country and site binders and the trial milestones.
Ensure the TMF is being maintained up-to-date and all essential documents are appropriately filed in the TMF.
Create and update financial information within the Ipsen financial K2 system (Internal Order, Purchase Order, goods receipt & invoices), if not managed by a dedicated position within the team
Responsible for tracking, collecting and disclosure of expenses in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US)
Ensure the complete data tracking by the CROs with the Data Collection Template (DCT), organize presentation of the instructions to the CROs if needed.
Check the data received from the CROs with the support of the CRM/CPM
Responsible for data entry and status updates within the Ipsen Clinical Trial Management System (CTMS)
Update the eCTMS with the CRO tracker information after validation with the CRM/CPM as per the CTMS user guide (at study, region and site level as applicable
Coordinate and conduct in-house and external clinical operations activities including generating contract templates within the Ipsen dedicated system (i-CAP), follow-up until the clinical study contracts are signed and secure proper filing and archiving of all fully executed contracts
Attend all study team meeting when appropriate and take meeting minutes
Perform any clinical study activity delegated by CRM/CPM such as the project management and monitoring of clinical studies, including liaison with monitors, CROs, drug vendors, central laboratories and other vendors
Be active member of dedicated working groups to achieve clinical operation excellence and harmonization by updating/revamping processes
Experience, Education and Specialized Knowledge and Skills:
2+ Years of Experience in clinical study environment within CRO or Pharmaceutical company.
Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out.
Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines
Ability to organize, prioritize tasks, identify and resolve issues efficiently. Manage multiple tasks effectively and follow through on assigned tasks.
Ability to receive general instructions on new assignments and perform routine work independently. Collaborate and work effectively within a team and within a multi-disciplinary environment.
Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form.
Attention to detail, accuracy and confidentiality.
Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods.
Work in a fast-paced, demanding and collaborative environment.
Demonstrate high ethical standards for honesty, truthfulness and integrity.
The pay range for this role is $108,336 to $120,242 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.
#J-18808-Ljbffr
