Senior Clinical Data Manager

  Medical Writing

Job title: Senior Clinical Data Manager

Company: Novartis

Job description: Job Description

50 Plus global studies will be the magnitude of the function to which you will be partnering as a team member. Within the Biometrics function you will be playing a key role in taking the accountability and delivering studies end to end of Data Management solutions. Will get opportunity to work on varied clinical studies of all phases which includes Interventional, Non- Interventional, Chart review, Observational, Prospective & Retrospective studies across all therapeutic areas.
At Novartis NBS CONEXTS we aim to provide innovative solutions to help Novartis medical and scientific teams re-imagine medicine, Delivering cost effective and scalable competitive solutions through focus on productivity, Building assets and competitive Novartis solutions, enhancing innovation and our unique service offering, Providing leading edge quality and innovation through our expert global workforce.
Your key responsibilities:
Your responsibilities include, but are not limited to:

  • Provide professional DM input as required on in-house and outsourced trials to relevant stakeholders. Participate in Clinical Trial Team/Data Review Team meetings as applicable . Input to and review of clinical trial database design including User Acceptance Testing (UAT).
  • Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study specific validation checks and necessary reports to ensure high quality and consistent data. Drive the same with data collection providers, as needed.
  • Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site/data review team, to ensure high quality and timely database locks.
  • Review and contribute to preparation of protocols as required to support stakeholders, specifically related to the data management section, visit schema, study design and standards.
  • Responsible for preparation of Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper. Drive the same with data collection providers, as needed.
  • For studies which have central data monitoring, CDME(central data monitoring ex-pert) will be responsible for all oversight of the data including DM deliverables. Will drive necessary actions as needed and ensure proper integration of central data monitoring requirements.
  • Support and provide leadership for data management staff for allocated trials. Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock. Drive the same with data collection providers, as required.
  • Perform training on data management software and practices or trial specific topics as required. Prepare training materials for data management activities and processes as required. Travel if required as needed.

Minimum requirements

  • University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree with atleast 5 years’ experience in drug development with at least 3 years’ experience in Data Management.
  • Understanding of clinical trial methodology, GCP and medical terminology
  • Good organizational and project management skills. Good communication and interpersonal skills
  • Intermediate presentation and problem solving skills
  • Ability to work well in a team
  • May coordinate and provide direction on task to other data management team members

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Functional Area

Research & Development

Division

CTS

Business Unit

NBS CONEXTS

Employment Type

Regular

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Expected salary:

Location: Hyderabad, Telangana

Job date: Wed, 02 Mar 2022 07:21:50 GMT

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