Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.
Post: Medical Surveillance - Assoc 1-1513560
Job Description:
PURPOSE
Under Supervision, provide a wide range of medical surveillance support including monitoring of clinical laboratory data for subjects in clinical studies, composing medical narratives and interfacing with investigator sites.
RESPONSIBILITIES
• Under supervision evaluating and analyzing laboratory results on a daily basis from sponsor designated central laboratory using sponsor-designated data management system.
• Under Supervision conduct the monitoring of laboratory safety parameters for each patient at every site throughout clinical drug trial.
• Under Supervision conducts preliminary review of laboratory results relative to established protocol-specific reference range guidelines.
• Follow established procedure for comparing current results with prior laboratory values to identify trends or potentially clinically significant increases/decreases.
• Under supervision, contact the investigator site for pertinent additional clinical assessment and consults with Sponsor/Quintiles physicians for medical evaluation of case, as needed.
• Under supervision, reviews and evaluates retest results and initiates contact with investigative site, if appropriate.
• Composes telephone reports documenting site contact to include all clinically relevant information. Distributes according to scheme designated at project inception.
• Assists Medical Surveillance Specialist with project set-up activities.
• Attends investigator/study start-up meetings as requested by Sponsor and/or Quintiles physicians.
• Maintains up-to-date laboratory knowledge via continuing education activities( like completion of continuing education class, applicable QU courses review of journal articles) or attendance at medical seminars.
• Attends project team meetings, as needed.
• Performs other related duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Basic Knowledge of Medical /Scientific Terminology
• Basic knowledge of applicable research and regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines
• Excellent organizational, communication and computer skills required.
• Ability to exercise excellent attention to detail.
• Ability to act independently and with initiative required to resolving problems.
• Strong analytical skills
• Strong Excel Skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor's/Master’s degree in Life science / Pharmacy / Medicine and up to 1 year of relevant experience in Clinical Research; or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
Additional Information:
Experience: Min. 1 year
Location: India
Education: B.Pharm, B.Sc, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Other
Last Date: 10th August, 2015
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