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Medical Manager

10.00 to 16.00 Years   Bangalore   16 Feb, 2021
Multi Recruit
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaApplication Programming / Maintenance
EmploymentTypeFull-time

Job Description

  • Provide the clinical team with training on therapeutic indication and/or treatment modality.
  • Provide the trials team with guidance in developing criteria for investigator site selection, networking for potential investigators, and aid in the review and final selection. Participate in subject recruitment and retention activities.
  • Presents protocol and safety reporting information at investigator meetings and develops medical monitoring plans. Provides the first-line contact for investigators for protocol queries and site support.
  • Follows procedures for acquiring knowledge of subject treatment assignments (i.e., breaking the blind)
  • Interacts with regulatory officials concerning safety and other study-related issues, as requested.
  • Provides a medical review of eCRFs and edit check specifications for clinical accuracy.
  • Provides Medical Data Review Plan as an appendix to the Medical Monitoring Plan.
  • Performs medical review of coded terms (e.g., adverse events, concomitant medications, and medical history) for medical accuracy and consistency.
  • Provides an individual and aggregate review of clinical data, laboratory data, data tables, listings, and figures. Reviews and/or writes portions of the final clinical study report.
  • Interacts with clients regarding device development programs, study design, and protocol development.
  • Reviews and provides medical and scientific input to new business proposals. Participates in feasibility discussions relating to specific project proposals. Obtains background information for new projects.
  • Participates in a variety of team quality improvement efforts as necessary
  • Performs other related duties as assigned by the Vice President Program management & Regulatory affairs
Requires Skills:
  • Ability to work in partnership with a multidisciplinary group of colleagues.
  • Outstanding ability to work independently with minimal supervision, ability to work effectively within a team.
  • Excellent oral and written communications skills, as well as interpersonal skills, are essential
  • MBBS is mandatory.
  • 10 years experience relevant to drug development and clinical research, including 3-5 years of the biopharmaceutical industry, academic, and/or clinical practice experience.

Keyskills :
e learningcontrollinginformation managementcasebudgeting

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