Job Description

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 <p>
  The award of new projects has resulted in opportunities arising for an enthusiastic, motivated and well experienced
  <strong>
   Principal Data Manager
  </strong>
  to join our George Clinical team!
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 <p>
  <strong>
   Who are we?
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   A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence
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   20+ years of experience, ~500 people managing 39+ geographical locations throughout the Asia-Pacific region, USA, and Europe
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   Full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trial
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   We combine scientific leadership and global operational excellence, with strong experience in renal medicine, oncology, cardiovascular and chronic diseases across various phases to improve the health of millions worldwide.
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  <strong>
   Why work with us?
  </strong>
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   We are a global team making a difference in the world &ndash; our clinical trials improve the health of millions worldwide
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   Competitive salary and benefits
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   Flexible and agile working arrangements - onsite, hybrid or WFH (dependent on location)
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   Strong and diverse Learning &amp; Development opportunities including exposure to all aspects of clinical trials with an unparalleled network of Scientific Leaders to learn from
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   A focus on employee well being including global employee engagement surveys, steps challenges, reward and recognition programs, team building activities and other fun events!
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  <strong>
   What does the role involve?
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  The Principal Data Manager (PDM) would act as a Subject Matter Expert (SME) for all Data Management (DM) tasks from study start-up to database lock. Primary responsibilities being Project Management (PM) and/or Line Management (LM), the role is expected to serve as Individual Contributor (IC) where required. The PDM would be responsible for the DM deliverables on time with expected quality and consistency, trouble shooting, people and process management
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   .
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  Ensure delivery of DM services for all studies within agreed timelines. This includes but is not limited to:
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   Act as the DM Project Manager for allocated studies by liaising with the stakeholders (external and internal) to determine study requirements, deliverables and timelines
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   Act as SME or super user for the nominated Electronic Data Capture (EDC) systems and undertake training to develop expertise, knowledge and skill in these systems including additional features such as Randomisation and Trial Supply Management (RTSM), Coder and Lab normal modules
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   Review &amp; development of high quality DM documents including Data Management Plans, Edit Specifications, Data Review Plans, Coding guidelines etc.
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   Supervising the DB design process focusing on testing and implementation of EDC systems including review of eCRF, annotated CRFs, and randomisation process in the allocated studies in accordance with GC SOPs
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   Ensure the DB specifications and Non-CRF data specifications (where necessary) are developed by the DB developer and approved prior to making the DB live
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   Perform and oversee the data review, query management and coding process in the allocated studies; perform DB lock (interim/final) and archive DBs in accordance with GC SOPs
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   Manage mid study updates by assessing the impact, reviewing the changes being performed and overseeing the implementation of changes to the live environment of the DB
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   Maintain quality in DM service at all times by performing timely quality reviews
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   Attend to study escalations and resolve study specific concerns from all stakeholders
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   Assist the Head of Data Management in finance management where required by tracking DM budget, costs and charges etc. and scope change management
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   Based on local requirements, a PDM in a particular geography may need to line manage the CDC, CDM I and/or CDM II roles. As part of this PDM is expected to mentor and train the staff to enable them to perform their allocated tasks
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   Conduct performance review of the reporting staff and give feedback to the Head, Data Management
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   Assist the Head of Data Management in resource management &amp; work allocation in accordance with organization&rsquo;s policies and applicable regulations
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   Perform vendor management activities based on local requirements in accordance with GC SOPs
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   Perform Business Development activities and represent GC DM in Bid Defence Meetings and audits
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   Maintain effective communications with cross-functional project teams and with external team members
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   Contribute to the development and maintenance of DM SOPs and standards
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  <strong>
   What are our expectations of candidates?
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   Tertiary qualifications in science or related field
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   Minimum of 12 years of experience in DM function with atleast 5 years of DM Lead experience.
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   Demonstrates excellent skills and thorough knowledge of the DM systems and processes
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   Experience with atleast three EDC tools, for e.g. RAVE, Zelta (Merative), Medrio or other such web-based data capture tools
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   Knowledge of Good Clinical Practice (GCP), applicable regulatory guidelines, especially related to data handling and processing, and Good Documentation Practice
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   Ability to evaluate and recommend changes to existing processes and procedures for greater effectiveness
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 </ul>
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  You must be willing to extend yourself and take on new challenges while living our values of
  <strong>
   Mutuality, Integrity, Can-do approach, Empowerment and Excellence
  </strong>
  alongside your colleagues globally - we keep each other in check and work better together!
 </p>
 <p>
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 <p>
  Apply via LinkedIn or send your
  <u>
   CV, referral or confidential query
  </u>
  to careers@georgeclinical.com and our friendly HR team across the world will reach out as appropriate soon. Please provide your full contact details, the location you are applying for, whether you are interested in a current or future opportunity and we'll be in touch. We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.
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 <p>
  Thank you for your interest in working with George Clinical. As a global business, we are committed to handling Personal Information in accordance with applicable privacy and data protection laws in the many countries in which we do business. Please see our Privacy Policy for further information.
 </p>
 <p>
  https://www.georgeclinical.com/privacy-policy-statement
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