Senior Clinical Regulatory BA | 10+ yrs, Planisware
TechDigital Group
An established industry player is seeking a seasoned Business Analyst with a strong clinical regulatory background. With over 10 years of experience in the Pharmaceutical and Biotech sectors, you will play a crucial role in enhancing clinical development processes and managing program portfolios. This position offers the chance to work with cutting-edge tools and technologies, including Planisware, Power BI, and Veeva Vault, to drive impactful analytics and forecasting. Join a dynamic team where your expertise will contribute to innovative solutions in the clinical landscape, making a real difference in patient outcomes. #J-18808-Ljbffr TechDigital Group
- GRAIL in Durham, NC, is hiring a Clinical Laboratory Technologist to perform laboratory tests that support clinical studies and maintain... ...have a Bachelor's degree in a life science and knowledge of regulatory compliance in laboratory settings. This full-time role...SeniorRegulatoryFull time
- Direct Jobs is seeking a leader for the Duke University Health System Clinical Laboratories. The role involves managing a multi-disciplinary team, ensuring accurate lab testing, and maintaining regulatory compliance. Candidates need a Bachelor's degree in Medical...SeniorRegulatory
- Creative Solutions Services, LLC is seeking a Contract Clinical Study Manager in Durham, NC. This role provides operational leadership... ...with hands-on study management, TMF oversight, and strong regulatory knowledge. Kubernetes, CTMS and data systems experience valued...SeniorRegulatoryContract work
$80k - $106k
The Supervisor, Clinical Laboratory oversees day‑to‑day operations of assigned laboratory areas... ..., efficiency, and compliance with regulatory and organizational standards. This role provides... ...is on the night shift working from 10:00 pm to 8:30 am EDT. You will work on‑site...RegulatoryFull timeWork at officeLocal areaFlexible hoursShift workNight shiftAfternoon shift$72.3k - $97.8k
The Institute For Medical Research, Inc. is seeking a Clinical Research Coordinator III in Durham, NC. The ideal candidate will manage clinical studies, ensuring adherence to protocols and regulatory standards. This role involves participant recruitment and coordination...SeniorRegulatoryFull time- A leading clinical research organization in Durham, North Carolina, is seeking a Senior Clinical Research Specialist to support oncology clinical trials. The role involves... ...quality, and maintaining compliance with regulatory standards. Candidates should have an Associate...SeniorRegulatory
- BioSpace seeks a Clinical Laboratory Technologist for its Durham, NC office. This role involves performing critical laboratory tests,... ...Bachelor’s degree in a life science field and has experience with regulatory standards. The position offers competitive salary, benefits,...SeniorRegulatoryWork at office
- ...implement them with quality and excellence. We are Worldwide Clinical Trials, a global team of over 3,500 experts, bright thinkers,... ...accuracy and integrity, which are crucial for groundbreaking regulatory submissions. The team includes data support staff, database and...SeniorRegulatoryWorldwide
- ...the DM department. Participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings. Perform... ...data management best practices & technologies as applied to clinical trials. Excellent communication and interpersonal skills to collaborate...SeniorRegulatoryWorldwide
- ...into hope through agile, patient-focused clinical development. We specialise in Phase I-IV... ...mid-sized CRO, we enable accelerated regulatory pathways, faster study start-up, and access... ...continues to grow, we're looking for a Senior CRA who is committed to clinical...SeniorRegulatoryContract workInterim roleRemote workWorldwide
- Position Summary The Duke Cancer Institute's Thoracic Clinical Research Program is looking for a Senior Clinical Research Specialist to join the Oncology... ...ethically, and in full compliance with protocol and regulatory requirements. Your work will support participant enrollment...SeniorRegulatoryWork experience placement
$100k - $115k
...must reside within the United States. 8-10 days on site per month being a mix of onsite... ...will utilize your skills, knowledge, and clinical judgement to provide a high standard of... ...adhered to according to the applicable regulatory requirements Ensure the integrity of the...SeniorRegulatoryWork at officeLocal areaRemote workNight shift$87.2k - $169.3k
...IQVIA Early Clinical Development is hiring for a Senior CRA 1. Ideal candidates will have Phase 1 experience across a variety of therapeutics. Seeking... ...clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work...SeniorRegulatoryFull timePart timeImmediate startWorldwide$20.76 - $31.44 per hour
Clinical Research Specialist, Senior - Duke Cancer Institute Work Arrangement: Hybrid (On‑Site and Remote mix) Location: Durham, NC, US, 27710 Date... ...and retention, data collection and management, regulatory documentation, and study coordination under the oversight...SeniorRegulatoryApprenticeshipRemote work$80k - $106k
Supervisor, Clinical Laboratory - Night Shift Location: Durham, NC. Shift: 10:00 pm to 8:30 am EDT. On‑site full‑time. Responsibilities Supervise daily laboratory... ...to SOPs, quality control measures, and regulatory requirements (e.g., CLIA, CAP, OSHA). Ensure accuracy...RegulatoryFull timeFlexible hoursShift workNight shiftAfternoon shift$93.1k - $232.8k
Job Overview Senior Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs... ...and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws,...SeniorRegulatoryFull timeContract workPart timeLocal areaImmediate start$70.1k - $145k
Syneos Health, Inc. in Morrisville, NC, is seeking a Senior Medical Writer to lead the writing of clinical and regulatory documents. This role requires expertise in FDA and ICH regulations and prior experience in the biopharmaceutical sector. Responsibilities include managing...SeniorRegulatory$93.1k - $232.8k
...bring breakthrough treatments to patients faster. Drive global clinical trials from first site activation to final patient visit—own... ...lead cross‑functional teams, and ensure compliance with ICH‑GCP, regulatory requirements, and study protocols . This is a highly visible...SeniorRegulatoryFull timeContract workPart timeWork at officeImmediate startWorldwide- Syneos Health, Inc. is seeking an Experienced Clinical Research Associate based in Morrisville, NC. The role involves overseeing the... ...qualification and monitoring activities to ensure compliance with regulatory standards. The ideal candidate will hold a Bachelor’s degree...SeniorRegulatoryFlexible hours
$69.36k - $110.66k
...Wellness, and multiple affiliations. Be You. The Oncology Clinical Research Unit (CRU) within the Duke Cancer Institute is... ...efficiently, ethically, and in compliance with institutional and regulatory requirements. This is an opportunity to take ownership of complex...SeniorRegulatoryFull timeWork experience placement- An established industry player is seeking a Business Analyst with a strong clinical regulatory background to join their team. This role requires a minimum of five years of experience in the Pharmaceutical or Biotech industry, along with a deep understanding of clinical...Regulatory
- Mandatory Skills - Business Analyst with Clinical Regulatory Background Minimum 10+ years of experience in Pharmaceutical/Biotech industry - Clinical... ...Snowflake, Power BI, MS Project and Office. Please note they must have: Planisware. #J-18808-Ljbffr TechDigital GroupRegulatory
- ...specified in the study protocol (plan). Regulatory agency's (e.g. FDA, EMA, etc.) guidelines... ...study director would be leading are pre-clinical in vitro studies conducted at the... ...employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up...SeniorRegulatoryWork at office
- Fortrea is looking for a Senior Director level leader for their Clinical Delivery Center of Excellence in Durham, North Carolina. This role requires extensive... ...relationships. The ideal candidate will have a minimum of 10 years in research and development, including a strong...Senior
$20.76 - $31.44 per hour
...Clinical Research Specialist, Senior (Spanish Bilingual) - School of Nursing Work Arrangement: Hybrid (On-Site and Remote mix) Location: Durham... ...electronic medical record, adverse event information, regulatory files, and secure project folders Apply regulatory and...SeniorRegulatoryApprenticeshipWork experience placementWork at officeRemote workAfternoon shift$93.1k - $232.8k
...IQVIA Biotech is seeking a Sr. Clinical Project Manager with experience in the following... ...treatments to patients faster. Overview The Senior Clinical Project Manager is a key leader... ...contractual requirements, SOPs, and regulatory standards. Develop and implement integrated...SeniorRegulatoryFull timePart timeImmediate start$56.99 - $71.32 per hour
...Clinical Study Manager Job Number: 366219 Category: Biologist Description... ...ICH/GCP guidelines, applicable regulatory requirements, company SOPs, study... ...Durham , NC Minimum Experience (yrs): 8 Required Education: Bachelor (BA, BS...) Benefits: Return to...RegulatoryContract workTemporary workWork at officeLocal areaImmediate startWorldwideShift work- Brighton Health Plan Solutions is seeking a Senior Director of Case Management & Outcomes Performance... ...programs, ensuring compliance with regulatory standards, and improving clinical outcomes. Ideal candidates will have 8-10 years of experience in healthcare leadership...SeniorRegulatory
$85k - $95k
...sciences solutions provider is seeking a Senior Quality & Compliance Analyst to oversee... ...product releases and ensure adherence to regulatory standards. Responsibilities include... .... Compensation ranges from $85,000 to $95,000 annually. #J-18808-Ljbffr Endpoint ClinicalSeniorRegulatory- ...Manager will bring innovation and future focused approaches to clinical trials with a focus on patient centricity and consistent... ...risk while adhering to professional standards, SOPs, client, and regulatory requirements. Partner with project team members and key stakeholders...SeniorRegulatoryContract workWork at officeLocal areaRemote workFlexible hoursNight shift
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