Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
Sr Mgr Global Trial Optimization
Location
United States + 1 moreAll locations: United States | United Kingdom
Posted
96 days ago
Salary
$134K - $219K / year
Seniority
Senior
No structured requirement data.
Job Description
Sr Mgr Global Trial Optimization
Regeneron Pharmaceuticals
The Senior Manager, Global Trial Optimization will lead program or study level activities advising on our clinical development strategy, clinical study concepts, study protocols and operational plans that will enable predictable delivery of clinical programs and studies. You will develop and maintain relationships with our external experts facilitating a wide source of country and disease area intelligence used in study design and operational planning. A typical day may include the following: • Lead study level feasibility processes to generate high quality and timely data to inform study design, efficient geographical placement and operational planning. • Partner with teams during CRO led feasibility activities supporting validation of study and country level enrollment rates and study start up timelines to advise budget and baseline setting. • Supports the development and implementation of the Global Trial Optimization function through process initiatives and change management. • Partner with Data and Analytics function to review and identify appropriate central data sources. • Articulate the data story to teams based on country level feasibility and centrally derived data to support data driven decisions to improve protocol design • Project management of study level country landscape assessment activities and the collection of targeted feasibility information for early assessment of operational feasibility for conducting clinical trials. • Lead study level engagements to acquire, analyze and deliver high quality targeted information from external partners. • Prove input into continuous improvement activities to ensure consistency of process execution. • In partnership with Clinical Outsourcing provide functional input into the identification, qualification and relationship management of a range of vendors. • Develop and implement patient recruitment and retention tactics aligned with defined study strategy. • Develop and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution • May require up to 20% travel To be considered a Bachelors degree in a related field with a minimum of 8 years of relevant industry experience within pharma/biotech, a CRO or consulting is required. Strong understanding and experience in operationalizing clinical development programs in a global setting from first-in-human to post-approval. Experience with feasibility. Must be a compelling communicator with ability to translate sophisticated messages to a variety of audiences. Additional requirements include: • Experience in using data to inform clinical strategy development • Ability to understand sophisticated business questions and develop effective solutions • Experience in process development, implementation and change management activities • Line management experience preferred Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $134,400.00 - $219,200.00
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Senior Clinical Research Associate
NateraFounded in 2004 and led by CEO Steve Chapman, Natera is a company in the biotechnology market that offers genetic testing and diagnostics on a global scale. Ope
POSITION SUMMARY: The Senior Clinical Research Associate is responsible for the overall operational execution of clinical studies on one or more clinical projects/programs; from study concept through study completion. This position will perform required job duties with guidance from Clinical Trial Managers to ensure that trial timelines, costs, and quality metrics are met, and the study is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements helps design and execute clinical research activities. PRIMARY RESPONSIBILITIES: - Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations - Develop study-related documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required - Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight - Support the Clinical Data Management team in the design and content of case report forms, completion guidelines, including support and testing of an EDC - Manage the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements - Overseeing clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information - Train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues - Monitor and track clinical trial progress, provide status updates to stakeholders - Develop new study monitoring plans, and monitor studies following study monitoring plans to identify protocol deviations or data discrepancies - Perform study activities including consent participants for research studies, ethics board submissions, participant data and sample tracking using in-house and CRO databases, for studies where Natera functions as a Clinical Research Site. - Update Clinical Department SOPs with guidance from CTM and/or Director - Partner with other research and development groups at Natera to achieve deliverables - Perform other duties as assigned - This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job. - Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, Human Subjects Protection, and GCP. - Must maintain a current status on Natera training requirements including General Policies, Procedure Compliance, and security training - Employee must pass post offer criminal background check QUALIFICATIONS: - BA/BS degree in life sciences, related field, or equivalent - Minimum of 4 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields KNOWLEDGE, SKILLS AND ABILITIES: - Experience with clinical EDC systems, - Familiarity with the organization and structure of the Trial Master File (TMF) - Familiarity with bio sample management, sample processing, and biobanking best practices - Competency in SOPs, ICH-GCP, FDA Regulations - Proficiency in MS Word, Excel and PowerPoint - Demonstrated ability to work independently and lead projects - Demonstrated analytical skills and ability to identify complicated problems and propose solutions - Strong interpersonal skills and communication skills (both written and oral) - Excellent writing skills - Detail oriented, with solid organization and time management skills The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Remote USA $99,400—$124,200 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.natera.com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page
• Lead and manage the day-to-day operational execution of assigned cell therapy trials: study startup, site activation, enrollment, monitoring, close-out. • Develop and manage study timelines, budgets, forecasts, and related operational metrics. • Partner with external vendors / CROs / service providers (monitoring, labs, imaging, manufacturing/supply chain for cell product) to ensure high quality and timely deliverables. • Serve as the primary cross-functional operational contact for study teams (clinical operations, data management, biostatistics, regulatory, safety/pharmacovigilance, manufacturing, supply chain, medical affairs, quality). • Ensure compliance with regulatory and quality standards (FDA, EMA, ICH-GCP, relevant local regulations) and internal SOPs. • Participate in protocol development and amendments, informed consent form (ICF) review, CRF/data tool development, TMF (Trial Master File) setup & maintenance, monitoring plan, data review plan, drug/cell-product accountability and reconciliation. • Oversee site feasibility, selection, contracting, start-up (site initiation visits, training, enrollment & retention strategies) and close-out activities. • Monitor study progress, identify risks/issues (enrollment delays, monitor/vendor performance, budget overruns, data quality issues) and implement mitigation strategies. • Foster effective communication across study teams, escalate issues to senior leadership as needed. • Ensure preparation for audits/inspections, maintain high standards of documentation readiness. • Contribute to lessons-learned and process improvement initiatives, particularly around cell-therapy-specific operational challenges (e.g., chain of identity/chain of custody, logistics of product, unique site training). • Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations. • Develop study documents and tools including study, informed consent forms, project plans, budgets, study templates, and other materials as needed. • Vendor Management – Contribute to or lead cross-program vendor management activities • Contribute to SOP development within the Clinical Operations team
Title: Clinical Research Associate Type: Remote - Field - Chicago/Wisconsin The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Manager. Accountabilities - Contributes to the selection of potential investigators. - In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. - Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. - Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. - Actively participates in Local Study Team (LST) meetings. - Contributes to National Investigators meetings, as applicable. - Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. - Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. - Updates CTMS and other systems with data from study sites as per required timelines. - Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. - Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSM the correct timing and type of visits. - Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. - Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. - Ensures data query resolution in a timely manner. - Works with data management to ensure robust quality of the collected study data. - Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. - Prepares and finalises monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP. - Follows up on outstanding actions with study sites to ensure resolution in a timely manner. - Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required. - Assists site in maintaining inspection ready ISF. - Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM. - Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSM or delegate. - Ensures that all study documents under their responsibility (i.e. site documents, relevant communications, etc) are available and ready for final archiving and completion of local part of the eTMF. - Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. - Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). - Ensures compliance with local, national and regional legislation, as applicable. - Collaborates with local MSLs as directed by LSM or line manager. Requirements: - Bachelors degree in related discipline, preferably in life science, or equivalent qualification (*). - Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. - Good medical knowledge and ability to learn relevant AZ Therapeutic Areas. - Basic understanding of the drug development process. - Good understanding of Clinical Study Management including monitoring, study drug handling and data management. - Excellent attention to details. - Good written and verbal communication skills. - Good collaboration and interpersonal skills. - Good negotiation skills. - Ability to travel nationally/internationally as required. - Valid driving license The annual base pay for this position ranges from $112,154.40 - $168,231.60. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 16-Mar-2026 Closing Date 03-Apr-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Remote Hospice Triage RN PT 10:30p-5a + rotating Sat & Sun 11:30p-8a CST
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