Clinical Operations Specialist

2 weeks ago

Bengaluru, Karnataka, India beBeeDataManager Full time ₹ 1,50,00,000 - ₹ 2,20,00,000

Job Description:

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As a seasoned Clinical Data Manager, you will lead and coordinate tasks related to clinical data management from start to finish.

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Key responsibilities include contributing to the efficient running of the CDM department, ensuring the completion of all CDM procedures according to contractual agreements and relevant SOPs and guidelines, proactively staying up-to-date with current clinical data management developments and systems, researching and providing input into in-house strategies and systems, performing medical coding activities on projects as assigned, and performing other reasonable tasks as requested by management.

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Project Management:

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  • Help plan and manage study timelines and resources",">
  • Manage progress against schedules and report to management",">
  • Perform project management across all functions for a study as appropriate",">
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Management of CRFs and Related Tasks:

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Management of allocated staff, allocation of projects in conjunction with Project Management as appropriate, performance reviews as required, administering training and development of staff as required, acting as the primary CDM contact both external and internal for Quanticate projects, managing work assignment and delivery of project tasks to the data processing and programming team as required, and line management responsibilities for any assigned direct reports including professional development training and performance appraisals.

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Required Skills and Qualifications:

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  • Qualified to an appropriate standard preferably to degree level in a life sciences subject",">
  • Six to Eight years of relevant experience in CRO Clinical Data Management domain including leading studies",">
  • Extensive knowledge of at least 2 Clinical Data Management systems such as Oracle Clinical Medidata Rave Inform",">
  • Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs especially as related to data handling and processing",">
  • CDM project leadership strong communication skills sound knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials proven ability in client relationship management",">
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Benefits:

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  • Competitive salary open to discussion based on experience",">
  • Flexible working hours",">
  • Holidays Annual Leave Sick Leave Casual Leave and Bank holidays",">
  • Medical Insurance for self and immediate family Gratuity Accidental Coverage",">
  • Quanticate offers a variety of different learning development opportunities to help you progress mentoring coaching e-learning job shadowing",">
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Keyword: DataManager

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