Clinical Document Management Process User Support - East Hanover, United States - Novartis

Novartis

Verified Company

East Hanover, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

About the Role:

Location:
#LI-Hybrid, #LI-Distance Worker

Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally.

In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working.

This role will be accountable for leading a team responsible for ensuring effective planning, delivery and oversight of user support and knowledge management activities in relation to clinical document management processes and systems across the Novartis organization,

Key Responsibilities:

Lead a team delivering user support and knowledge management activities related to the delivery of capability and learning services to help drive adoption of Trial Master File (TMF) and good documentation practices across the business.
Identifies, plans and drives implementation of CDGM initiatives, projects and process improvement activities to improve clinical document management user support and knowledge management at Novartis.
Act as CDGM user support and knowledge management contact for key stakeholders, collaborating with them to improve clinical documentation process, systems and capabilities across the organization.
Delivers excellence in service delivery, including optimization and simplification in compliance with Novartis policies & regulatory requirements, responding in an agile way to new or evolving business priorities.
Provide robust oversight of 3rd party vendor activities including monitoring balanced performance against SLAs.

Lead or give to multi-functional initiatives or projects, including defining and gaining approval for projects or initiatives, and ensuring work is achieved in line with agreed timeframes and budget.

Embeds a riskbased approach across the team and in service delivery, ensuring identification, evaluation and management of risks, including mitigation activities.

Set priorities, handle schedules and develop robust resourcing model to support timely delivery of TMF services.

Support CDGM and business teams in preparation for and during audits, inspections and migration activities. Own CAPAs arising from inspections/audits ensuring they are closed out on time.
Leads team, recruits, retains, manages and develops associates through coaching and feedback, talent reviews and other available Novartis resources and tools, and champions a safe environment for team dialogue and growth.

**The ideal location for this role is the East Hanover, NJ site but a distant working arrangement may be possible in certain states. Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to the East Hanover, NJ site, as determined necessary by hiring manager. This position will require mínimal travel as defined by the business (domestic and or international).

Diversity & Inclusion / EEO:

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential._

Role Requirements:

Essential Requirements:

Education: Advanced degree or combination of Bachelor's degree in lifesciences/healthcare/pharmacy and relevant Industry experience.
Minimum of 8 years of working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organization) with specific experience in clinical documentation and/or records & information management.
Minimum of 3 years' experience in direct people management or matrix management of project/clinical teams.
Deep understanding of drug development process, international drug approval procedures and standards (e.g., ICH-E3, ICH-E6, eCTD) and industrywide standards in clinical document management (e.g., DIA TMF reference model).
Demonstrated success in planning and driving multifunctional projects.
Strong influencing and presentation skills. Ability to communicate effectively at all levels.

Desired Experience:

Good organizational awareness, including experience working in multidisciplinary teams, across cultures and geographies.
Good negotiation, problem solving and conflict resolution skills; experience establishing positi