Business Analyst - Clinical Regulatory
TechDigital Group
Mandatory Skills - Business Analyst with Clinical Regulatory Background Minimum 10+ years of experience in Pharmaceutical/Biotech industry – Clinical Development processes, program and portfolio management, forecasting and analytics preferred. CRO services, SaaS vendors; IT Infrastructure operations. Tools/Technologies: simulation tools, SSO; ALM VERA; Veeva Vault, eTMF, Snowflake, Power BI, MS Project and Office. Please note they must have: Planisware. #J-18808-Ljbffr TechDigital Group
- ...Business Analyst With Clinical Regulatory Background Mandatory skills: Minimum 5 years of experience in pharmaceutical/biotech industry SaaS vendors; relationship with internal business groups. Tools and technology awareness: ServiceNow, ALM VERA, document management...Regulatory
- ...lives. The company maintains a portfolio of clinical programs across a range of neuromuscular... ...Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, Nonclinical... ...support technical due diligence in Business Development & Licensing (BD&L)...RegulatoryFull timeLocal areaRemote work
- A biopharmaceutical company is seeking a Medical Director for Clinical Development in Oncology. The position involves leading oncology... ...medical and scientific guidance, and ensuring compliance with regulatory standards. Candidates should hold an MD or equivalent with...Regulatory
- ...lives. The company maintains a portfolio of clinical programs across a range of neuromuscular... ...Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, Non... ...May support technical due diligence in Business Development & Licensing activities. Minimum...RegulatoryLocal area
$220k - $245k
Fortrea in Durham is seeking an executive leader for Quality Assurance and Regulatory Compliance in the Clinical Pharmacology Services business unit. This role requires 15+ years of experience and expertise in GCP and GMP, with a focus on clinical pharmacology. The successful...Regulatory- ...Organizes and streamlines data to facilitate business decisions using data visualization tools... ...and client-requested enhancements with regulatory awareness and process management.... ...and service improvements.Mentors junior analysts.Performs independent and complex technical...RegulatoryFull time
- ...DEPARTMENT: Clinical Operations LOCATION: Durham, NC, Partially Remote COMPANY:... ...Reports (CSR), and Clinical aspects of Regulatory dossiers Develop and guide the execution... ...critical thinker with solid interpersonal and business communication skills. ~ Represents the...RegulatoryTemporary workLocal areaRemote workVisa sponsorship
- IQVIA is seeking a seasoned QA leader to provide strategic oversight across GxP-regulated programs, with emphasis on clinical research, regulatory adherence, and patient safety. You will drive risk-based decision making, CAPA effectiveness, and continuous improvement across...Regulatory
- ...Executive Director, Clinical Platforms & Product Development About the Company Well-established contract research organization... ...must ensure alignment with the clinical trial delivery model, regulatory environment, and sponsor expectations. Applicants must have a...RegulatoryContract work
- Definium Therapeutics, a late-stage clinical biopharmaceutical company, seeks a Clinical Science lead to guide global CNS development... ...cross-functional collaboration to support study execution and regulatory submissions. The role requires a Doctoral degree and 3+ years...Regulatory
- Immunovant, Inc. is seeking a senior leader to oversee the clinical data technology ecosystem, including eCOA/ePRO, eDiary, Medidata... ...leads a dedicated platforms team to ensure data integrity and regulatory readiness. You will partner with cross-functional teams, manage...Regulatory
- GRAIL is seeking a Supervisor, Clinical Laboratory for our Durham, NC site. This on-site, full-time role oversees night-shift laboratory... ...10:00 pm to 8:30 am EDT, ensuring accuracy, efficiency and regulatory compliance. You will supervise laboratory associates and technical...RegulatoryFull timeNight shift
$60 - $70 per hour
...SAP Business AnalystOur client, a leader in enterprise transformation within the manufacturing... ...sectors, is seeking a SAP Business Analyst to join their team. As a SAP Business Analyst... ...ensure solutions meet operational and regulatory needs.Lead testing activities including...Regulatory- ....Labcorp is seeking a Medical Director, Clinical Development - MRD Portfolio (Solid Tumors... ..., medical affairs, market access, regulatory affairs, commercial, and executive leadership... ...objectives with organizational goals and business strategy.Foster a culture of scientific...RegulatoryTemporary workCasual workInternshipMonday to FridayFlexible hours
$59.83k - $99.96k
Duke PF in Durham, NC is seeking a Clinical Research Coordinator (Spanish Bilingual) for a full-time, grant-funded role within the School... ...recruiting participants, leading study visits, and ensuring regulatory compliance for research on traumatic brain injury. The ideal...RegulatoryFull time$169.81k - $192.24k
Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying... ...quality, coordination, and timeliness of clinical sections of regulatory deliverables (e.g., INDs, Investigator Brochures, CTAs, ISS/...RegulatoryFlexible hours$88.6k - $246.6k
...Assurance (QA) programs, with a strong focus on clinical research, clinical operations,... ...outcomes across multiple functional areas, business units, and customer engagements through... ...and promote compliance with applicable regulatory requirements, industry guidelines, and company...RegulatoryFull timePart timeWork at officeImmediate startWorldwide- ...recommendations, and ensure work complies with policies, procedures, and regulatory requirements. Devoted to providing technical support,... ...; developing performance measures; developing and updating business plans and assisting with strategic planning. As assigned, an...RegulatoryFull timeTemporary workPart timeShift workNight shiftRotating shift
- Duke HomeCare & Hospice seeks a Clinical Nurse Educator to support Home Health, Hospice and Home Infusion across the region. You will... ...for Dorothy and Comfort EMR products and guide teams through regulatory updates and new programs. You will participate in General Orientation...Regulatory
- Jobtailor is seeking a registered nurse to coordinate oncology clinical trials in Durham, North Carolina. You will recruit, screen,... ...participants while ensuring adherence to study protocols and regulatory requirements in a hospital research setting. The role includes...Regulatory
- ...This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our... ...people see brilliantly. The Manager, Good Clinical Practices (GCP) is primarily responsible... ...are designed to align incentives with business objectives, support our values, and...RegulatoryLocal areaRelocationFlexible hours
- ...Responsibilities Coordinate and manage oncology clinical trials by recruiting, screening, consenting, and enrolling participants while ensuring adherence to study protocols and regulatory requirements Deliver direct patient care in a research setting, including medication...Regulatory
$80k - $106k
The Supervisor, Clinical Laboratory oversees day-to-day operations of assigned laboratory areas, ensuring accuracy, efficiency, and compliance with regulatory and organizational standards. This role provides direct supervision to laboratory associates and technical staff...RegulatoryFull timeWork at officeLocal areaFlexible hoursShift workNight shiftAfternoon shift- ...Assistance (based on eligibility) Duke University Hospital Endoscopy Clinic seeks to hire an experienced Nurse Manager who embraces our... ...is responsible for ensuring high standards of patient care, regulatory compliance, and operational excellence in alignment with DUHS policies...RegulatoryRelocation package
- ...and Trials Unit within the Duke Human Vaccine Institute seeks a Clinical Research Nurse Coordinator (CRNC). The role integrates nursing... ...and BLS. Responsibilities cover accurate documentation, regulatory compliance, and coordination of complex study visits in a collaborative...Regulatory
- Pedestal Health is seeking a Study Start-Up and Regulatory Manager to lead regulatory and start-up activities for multiple clinical research projects. You will act as the SME for IRB/IEC submissions, essential documents, and TMF maintenance, ensuring activation and audit...Regulatory
- 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...Regulatory
- ...alert: Nurse Manager Operations (NM-AC) Endoscopy, Ambulatory Clinic Work Arrangement: Requisition Number: 272642 Regular or Temporary... ...is responsible for ensuring high standards of patient care, regulatory compliance, and operational excellence in alignment with DUHS...RegulatoryTemporary workRelocation package
$74.2k - $185.4k
...country where the job is located.Job OverviewSecure and retain business through professional, consultative, proactive sales activities... ...at decisionmakers and decision influencers at existing and new clinical sponsors.Essential FunctionsDrive revenue growth by proactively...Full timePart timeImmediate startWorldwide- ...focus to provide strategic oversight of clinical research programs from proposal through... ...execution in Durham, NC. You will partner with Business Development and Operations to drive... ..., financial performance, and regulatory compliance. This role also entails mentoring...Regulatory
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