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Online Resumes with "SAE Reporting"
CTA
Seeking for a challenging career in a progressive organization offering the opportunity for contributing my skills services to the organization and personal growth and to work sincerely with maximum effort using best talents and with a challenge to achieve required goals and targets, abiding to the decisions of seniors and to earn a good reputation what ever required.
Tags for this Online Resume: Develop, maintain and manage appropriate study documentation, Developing, writing and presenting the clinical trial protocols, Initiate, maintain and reconcile Trial Master File., Monitoring the trial throughout its duration which will involve visiting the Study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise., Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other Data collection tools by careful source document review Monitor data for missing of implausible data., Complete Serious Adverse Event (SAE) reporting, process production of Reports, narratives and follow up of SAEs and managing the clinical data intermilitently as per 21CFR USFDA guidelines, Monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines., Independently perform CRF review; query generation and resolution against established data review guidelines on client data management systems as assigned Perform other duties as assigned by management., , maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
Lead Project Manager- Clinical Trials
Proven expertise in managing teams, streamline project paths encompassing an understanding of scientific data, analysis and interpretation of results, clinical developability and commercial viability of projects.
Ideal Companies: Vertex Pharmaceuticals, Amgen Inc., Takeda Pharmaceuticals
Senior/ Lead Clinical Reseach Associate - over 15 years experience monitoring, site management, medical record review, training/mentoring junior CRAs. database locks. regional clinical team leader
My goal is to secure a regional, home-based position in which I can use my knowledge of all phases of clinical research to develop tools to collect data (CRFs/edit checks; to verify the data (site management/monitoring), clean data (database locks)and to insure patient safety by assuring all AE/SAEs are reported, protcols and infomed consent are IRBs approved and adherence to all ICH guidelines and regulations.
Tags for this Online Resume: Lead CRA, Data Manager, Sr. CRA, Regional CRA
Clinical Research Specialist/ Scientist (Oncology) - 8 years experience- Clinical Trial Investigator – Clinical Research Pharmacist - Pharmacokinetics modeling- Clinical protocol, IB & ICF authoring - IND submission – SAE reporting - Pharmacovigila
A challenging position as a Clinical Research Scientist in an industry which is making significant and creative efforts contributing to the advanced understanding of cancer and devoting to the clinical development of novel anticancer agents. Very interested in joining a pharmaceutical company where I can change a life, make a dream come true, light the way for a better tomorrow, and moving oncology forward.
Tags for this Online Resume: Clinical scientist, Pharmacovigilance, drug safety, oncology
Coordinator clinical trials, data manager, research, oncology
Data management positions, preferably home based, clinical trial coordination or specialist, full time with benefits and prospects for growth, continuing education
Tags for this Online Resume: research, data management, SAE reporting, oncology, neuroscience, liason, regulatory
Clinical Research Associate
SUMMARY OF QUALIFICATIONS • Foreign graduate Medical Doctor and licensed RN with more than 22 years of clinical and research experience. US citizen. Fluent in English, Russian and Romanian • Extensive training in Good Clinical Practices, ICH Guidelines, SOPs through various Sponsors • In depth therapeutic and protocol knowledge as per Sponsor’s assignment. Excellent organizational and problem-solving skills.
Ideal Companies: Biotech companies
Tags for this Online Resume: research associate, biotech, CRA, Las Vegas, pharmaceutical, health
Featured Profile
Clinical Research - 15 Years of Experience - Near 90001
I am seeking a position in Clinical Trial Management or as a Project Manager per my previous US and international experience.
Ideal Companies: Pharmaceutical or Biotech
Tags for this Online Resume:
Oncology, Orthopedics, Surgical, Clinical Research, Management, Medical, Medical Affairs, Diabetes, Cardiovascular, Women's Health, Clinical Trial Management, Regulatory, Medical Writing, Microsoft, CTMS
Global Drug Safety professional
Drug safety, medical monitoring professional with 7 years in drug safety and over 15 years in clinical research, pursuing challenging drug safety lead position where my education, experience and knowledge can be implemented and utilized accordingly
Tags for this Online Resume:
NJ, Drug Safety Director/Medical Monitor, Signal detection, causality relatedmess assesment and determination, SAE reports and line listings, RMP, , coding review and approval, approve, protocol, IB, DSUR, PSUR, SOP's, etc, Assist with BLA, IND, MAA in EMEA , DSMB, KOL, Site and vendor selection.
Lead Clinical Research Coordinator - 4+ Years of Experience - Near 48304
Tags for this Online Resume:
SPSS, CCRP, IRB documents, Multicenter Clinical Trials, SAE reporting, Data management, internal monitoring, GCP and FDA regulations
Clinical Research Associate - 5+ Years of Experience
Experienced with key clinical trial systems including CTMS, EDC, IVRS and eTMF systems,Recist1.0,ECOG,statistical concept
Ideal Companies: Roche, Pharm-Olam
Tags for this Online Resume:
Clinical Research, Compliance, Documentation, Research, Good Clinical Practices, Management, Oncology, Protocol, Cardiovascular, Data Management, CTMS, EDC, SAE reporting
Clinical Research - 7 Years of Experience - Near 10803
Qualification Highly motivated and accomplished Clinical Research Coordinator with extensive skills and experience. Nine years of experience as an Oncology research coordinator. Proven ability to manage multiple studies simultaneously. Managed phase 1b - IV protocols according to GCP and FDA guidelines. Experience as a supervisor and mentor to study coordinators across various oncology disease sites. Trained staff on study ...
Tags for this Online Resume:
Appraisals, Audit, Clinical Research, Data Quality, Documentation, Management, Protocol, Quality, Quality Assurance, Recruiting
Clinical Research - 15 Years of Experience - Near 90001
I am seeking a position in Clinical Trial Management or as a Project Manager per my previous US and international experience.
Ideal Companies: Pharmaceutical or Biotech
Tags for this Online Resume: Oncology, Orthopedics, Surgical, Clinical Research, Management, Medical, Medical Affairs, Diabetes, Cardiovascular, Women's Health, Clinical Trial Management, Regulatory, Medical Writing, Microsoft, CTMS
