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Biostatistician
Must have clinical trial experience including: • A minimum of 4 years for Ph.D (6 years for MS) working experience in pharmaceutical and/or Biotech Company. • Advanced knowledge of statistical methods in clinical study designs, clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS). • Must have worked on statistical analysis plans, study protocols, clinical study reports, investigator Brochures, and annual reports (or periodic safety update reports). Oncology or Rare Disease experience is a plus....
Tags for this job: SAS, statistical analysis, CDISC, SDTM, ADam, esubmission, statistician, biostatistician, PhD
View Biostatistician Job - San Francisco, CA 94158
Technical Field Specialist
The Technical Field Specialist is responsible for ensuring the Contract Manufacturing Organizations (CMO) that the client works with are carrying out the agreed upon commercial manufacturing process for the products. The Technical Field Specialist audits CMOs against established manufacturing process and observes quality control test procedures. Responsibilities: • Obtain, expand and maintain full understanding of manufacturing and analytical procedures • Conduct site visits to contract manufacturing organization (CMO) facilities to observe production and testing of...
Tags for this job: CMO, audit, PET,technical field specialist
View Technical Field Specialist Job - Philadelphia, PA 19104
Quality Control Analyst II
This position will support the organization of the QC Biochemistry laboratory. Primary responsibilities for this position include method validation and transfer for biochemistry assays (SDS-PAGE, Threshold, SRD, and UV/Vis spectrometry). Primary Functions: • • Subject Matter Expert for biochemistry assays (SDS-PAGE, Threshold, and UV/Vis spectrometry) • • Author SOPs, protocols and technical reports • • Perform Method transfers, qualifications and validations • • Peer review of laboratory data • • Author SOPs, protocols and technical reports • • Investigate...
Tags for this job: SDS,UV/VIS, method validation
View Quality Control Analyst II Job - Holly Springs, NC 27540
Drug Safety Associate
Receive incoming adverse event/safety related inquiries via telephone, e-mail, or fax, from the medical community, patients, and caregivers regarding all products across all therapeutic areas Collect adverse event data based on focused, targeted, medically relevant questions utilizing healthcare experience and knowledge Appropriately and accurately document incoming reports of adverse events (AE), and triage the information in accordance with Standard Operating Procedures, working instructions, and/or policies. Document and triage other non-safety related inqui...
Tags for this job: adverse event, drug safety, nurse, narrative, triage, case processing
View Drug Safety Associate Job - Smyrna, GA 30080
Permanent CRA - Southeast
ClinForce has Permanent Regional CRA opportunities available around the country. General Minimum Requirements: • Bachelor's degree in a health care or other scientific discipline or educational equivalent • Minimum of 2 years of CRA field monitoring experience. Candidates with only co-monitoring or device experience will be considered. • Willing to travel 75-80% • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint • Excellent organizational and problem-solving skills
Tags for this job: Clinical Research Associate, Monitor, CRA, Clinical Monitor, Regional CRA, Regional Monitor, Clinical Research, Clinical Trials, Study Monitor, Monitoring
View Permanent CRA - Southeast Job - Raleigh, NC 27604