340084BR
May 11, 2022
South Africa

Job Description

This role is responsible for leading the planning, execution, reporting and budget oversight of Medical Affairs evidence generation activities: Non-interventional studies (NIS Primary data collection (PDC) and Secondary Use of Data (SUD)), Investigator Initiated trials (IIT) and Research Collaborations. Build operational expertise in GMA to optimize development of study concept and early pricing, support feasibility and implementation of new initiatives for Phase IIIb/IV interventional trials and NIS Primary data collection (PDC). Drives operational excellence through process improvement, business performance metrics and knowledge sharing across GH Medical Affairs.
Key strategic partner to the Global Medical Head (GMH), Global Medical Affairs Director (GMAD) and relevant Line Functions (LF) such as Finance, Scientific Engagements & Communication, GDO and CD&A to achieve GH Medical Affairs objectives for all evidence generation activities. Enables a collaborative and empowered organization that can navigate in a matrix environment and adjust quickly to business needs.

Major Accountabilities:

 Lead the operational planning, development, execution, reporting, risk mitigation and innovation of evidence generation activities (NIS PDC and SUD, IIT, Research Collabo-ration); Supporting forecast and management of drug supply as applicable; Drive operational execution of NIS PDC.
 For global Phase IIIb/IV interventional trials, provide operational input to early development of study concept and early pricing, feasibility and implementation of new initiatives until handing over to GDO for execution. Oversee progress of Phase IIIb/IV interventional trials
 Provide operational input to medical plan for evidence generation; Coordinate meeting and reviews as applicable. Oversee budget forecast and management for accuracy
 Lead and manage the cross-functional team to ensure deliverables are met within the established timelines, budget and quality/compliance standards; accountable for representation at all internal meetings, participate and report activity progress and issues/resolution plan.
 Develop outsourcing specifications (as required) to facilitate bid process and selection of External service providers; manage interface with ESPs in cooperation with outsourcing management and relevant line functions; ensure vendors meet quality standards; contribute to the development/amendment of vendor contracts;
 Create new activities and maintain CTMS and other systems up to date
 In collaboration with Scientific Engagement & Communication, drive functional excellence in education, implementation and compliance to best practices for medical affairs, including sharing lessons learned across GH programs.
 Serve as Subject Matter Expert (SME) representing GH Medical Affairs for SOPs, Working Practices, guidelines and guidance’s development or revisions
 Key contributor to GH program forums, initiatives or working groups. May serve as faculty member for Scientific Capability Building programs

Diversity & Inclusion / EEO

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

Minimum Requirements

Education (minimum/desirable):
Advanced degree or equivalent education/degree in life science/healthcare preferred

Languages: English

Experience:

• ≥5 years of operational and managerial experience in planning, executing, reporting global clinical trials in a pharmaceutical company or a contract research organization.
• Proficient communication, influencing and negotiating skills. Strong project management skills and demonstrated ability to meet timelines.
• Proven ability to work independently in a complex matrix environment (including remote or virtual team environment).
• Experience in developing effective working relationships with internal and external stakeholders
• Organizational awareness, including experience working cross-functionally and in global teams.
• Strong interpersonal, problem-solving, negotiation and conflict resolution skills.
• Established knowledge of Good Clinical Practice, clinical trial design and global drug development process.
• Proven record of managing budget

Location:
South Africa/India/Kenya
PHARMA
Global Health PH
South Africa
Gauteng
Research & Development
Full Time
Regular
No
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340084BR

Expert Global Clinical Trial Manager

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