- ThermoFisher Scientific (Greenville, NC)
- …minimize delays and execute high-quality, cost-efficient clinical studies. As a Clinical Team Manager (CTM)/ Local Study Manager , you combine deep knowledge, ... complexity and may assume regional lead or Clinical Study Manager responsibilities. **Essential Functions:** - Manages all clinical operational...content and quality of the relevant sections of the Trial Master File ( local and central). -… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** Clinical Operations Oncology is responsible for the worldwide execution of all Phase 1 through ... 3 clinical trials within the Oncology Therapeutic Area. Clinical Operations plays a key role...Depending on business need, may manage Clinical Project Assistant/Clinical Trial Management Assistant/Sr. Clinical Trial Management Assistant… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ability to deliver live changing therapeutics to those in need._ **Clinical Trials Manager , Clinical Operations - Oncology (CTM)** **We are seeking a talented, ... Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking a ** Manager ** to join our Clinical Sciences, Oncology team. You will work in a highly collaborative environment as part of a cross-functional ... and deliver on clinical studies and programs. **As a Manager in Oncology Clinical Sciences, a typical...and ICH/GCP guidelines. Experience with medical writing and clinical trial process improvements strongly preferred. Does this sound like… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in ... oncology , as well as other research areas centered around...the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy… more
- AbbVie (Mettawa, IL)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... of pricing, contracting and other access strategies. MAJOR RESPONSIBILITIES Lead Oncology related project and provide insights that influence Abbvie business… more
- IQVIA (Wayne, PA)
- …members; in collaboration with the Study Responsible Physician (SRP). Oversee the Clinical Trial Manager (CTM) in the set[1]up and coordination of Investigator ... local regulatory requirements, etc. * Leads the cross-functional Trial Team, tracking of project deliverables and timelines using...Is primary point of contact for the assigned Project Director/ Manager from the CRO responsible for the trial… more
- BeiGene (Emeryville, CA)
- …on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at ... that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …data and interprets results from clinical trials and of data from non- trial sources to facilitate program-level decision making. + Prepare presentations and written ... in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians. **To be… more
- Catholic Health Initiatives (Lexington, KY)
- **Overview** The Oncology Clinical Research Nurse (CRN) works with the CommonSpirit Health Research Institute Market Clinical Research Manager (MCRM), Principal ... as well as CommonSpirit Health policy. This position will support the Oncology departments within the Kentucky market. This position is responsible for maintaining… more
- MD Anderson Cancer Center (Houston, TX)
- …research documents and tools to aid in successfully meeting clinical trial requirements. . Notifies clinical and/or research laboratories of protocol-required ... to ensure preparedness for industry, institutional, and federal clinical trial audits. . Utilizes the OneConnect system to make...systems; . Under the direction of the Research Nurse Manager and/or Supervisors, the Sr. Research Nurse will aid… more
- MD Anderson Cancer Center (Houston, TX)
- …world through exceptional programs that integrate patient care, research and prevention. Oncology nursing excellence is a central pillar in MD Anderson's worldwide ... Magnet Recognized hospital, we provide our patients with excellent oncology nursing care. Our values are caring, integrity, discovery,...Mentoring : Under the direction of the Research Nurse Manager , the Sr. Research Nurse will aid in mentoring,… more
- Gilead Sciences, Inc. (Seattle, WA)
- …and regulatory documentation and SOPs. + Meets all requirements for Senior Clinical Trial Manager (Senior CTM) grade 28 position with demonstrable proficiency. ... Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials. + Ensures team's… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to ... CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred + If you have a high...salary ranges are shown in accordance with the applicable local law and currency. If you are outside the… more
- MD Anderson Cancer Center (Houston, TX)
- Senior Coordinator, Clinical Studies - Thoracic-Head & Neck Medical Oncology JOB SPECIFIC COMPETENCIES Protocol Management -Independently performs protocol-specific ... IRB protocol and/or per grant specifications. - Participate in clinical trial activation committees for streamlining processes and improving submission and… more
- Actalent (Celebration, FL)
- …of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, Food and Drug Administration (FDA) regulations and International ... consent as an ongoing process, that the rights, safety and well-being of trial subjects are the most important considerations and should prevail over the interests… more
- MD Anderson Cancer Center (Houston, TX)
- …supervision of the protocol primary investigator (PI), the research nurse manager and/or clinical studies supervisor, assumes responsibility for the overall ... research documents and tools to aid in successfully meeting clinical trial requirements. Participates in development of protocol-specific treatment plans/orders, as… more
- MD Anderson Cancer Center (Houston, TX)
- …or shipped. Accessions material into appropriate laboratory system, depending on trial . Participate in all preparation, reporting, and Sponsor Site visitations ... quantities of daily supplies are always on hand. Works with the supervisor manager to place monthly orders and monitors inventories. Ensures the inventory room is… more
- MD Anderson Cancer Center (Houston, TX)
- …. Participates in the submission process of Continuing Reviews in consultation with the trial manager , and PI for Investigational New Drug (IND) reports, sponsor ... designated. . Consults with PI and the Research Nurse Manager regarding ongoing study assignments. Collaborates with other members...protected by institutional policy or by federal, state or local laws unless such distinction is required by law.… more
- MD Anderson Cancer Center (Houston, TX)
- …. Participates in the submission process of Continuing Reviews in consultation with the trial manager , and PI for Investigational New Drug (IND) reports, sponsor ... designated . Consults with PI and the Research Nurse Manager regarding ongoing study assignments. Collaborates with other members...protected by institutional policy or by federal, state or local laws unless such distinction is required by law.… more