Project Support Coordinator Ii

Year    Bengaluru, Karnataka, India

Job Description

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Work Schedule Standard (Mon-Fri) Environmental Conditions Office
  • Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
  • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
  • Ensures allocated tasks are performed on time, within budget and to a high quality standard. Escalates in cases of variances (overburn/underburn).
  • Supports the maintenance of study specific documentation and systems including, but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.
  • Provides system (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, tracking study level documents and maintaining audit readiness.
  • Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRG\'s/Client eTMF as required, performing CRG\'s/Client eTMF reviews and coordinating for issue resolution, performing mass mailings and communications as needed, providing documents and reports to internal team members.
  • Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes.
  • Exports and prepare study metrics reports.
  • Maintain vendor trackers.
  • Assists with coordination and compilation of Investigator Site File (ISF) template and pharmacy binder, with instruction from the Clinical Team Manager.
  • When required attends Kick off and Project Launch meetings and takes notes, supports initial study set-up.
Qualifications: Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). Knowledge, Skills and Abilities:
  • Ability to work in a team or independently as required
  • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
  • Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
  • Strong customer focus
  • Good time management skills. Flexibility to reprioritize workload to meet changing project timelines
  • Demonstrated ability to attain and maintain a good working knowledge of applicable Country
Regulations (if required), ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
  • Good English language and grammar skills and proficient local language skills (if required). Effective oral and written communication skills
  • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and learn the required clinical trial systems
  • Ability to successfully complete CRG training program
  • Self-motivated, positive attitude and good interpersonal skills

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Job Detail

  • Job Id
    JD3316316
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Bengaluru, Karnataka, India
  • Education
    Not mentioned
  • Experience
    Year