CTA IND Project Manager

Job content

Site Name: Italy - Siena, UK - London - Brentford, Belgium-Wavre
Posted Date: Jun 21 2021

The CTA IND Project Manager delivers project management, compliance and regulatory intelligence in the framework of the End-To-End Investigational Products Application Submission process to local competent authorities (EU, Int’l countries, US).

The CTA IND Project Manager could be located in the different R&D Centers (UK - Belgium – Italy – US…).

The CTA IND Project Manager provides technical/coordination support and expertise within GSK R&D (eg: GRA (TG – CMC – Reg LOC…) – Clin Ops (Asset Lead – SDL - LDL – Scientific Writer – Public Disclosure)… – Safety –…), Global Quality (eg: QA Release) & Legal/Patent departments and outside GSK (eg: EMA – local competent authorities such as AFMPS…) to ensure the appropriate project management related to E2E Investigational Products Application Submission process with the different stakeholders by issuing the master planning/strategy to ensure timely due submissions and approvals of Clinical Trials in compliance with regulatory standards.

As Regulatory Clinical Trial Process expert, the CTA IND Project Manager maintains a good level of knowledge of the business and regulatory evolutions in the field and looks for continuous improvement of the processes implementing needed business requirements for GSK.

Key Responsibilities

Expertise process

The CTA IND Project Manager ensures the following project management for Clinical Trial Submission by:

• defining the Clinical Trial Submission strategy within R&D and managing the planning, coordination and/or preparation, dispatch and follow-up on the initial clinical trial application file, Q&A’s, amendments, end of trial notification and summary of clinical trial report in order to ensure a timely submission to appropriate authorities such as Competent Authorities maintaining GRA TMF compliance the upload and maintenance of the third country form (related to articles 41 & 46) via the EMA gateway flagging operational issues and proposing solutions in a timely manner supporting the Regulatory and Clinical LOCs for their submission to their authority by providing help and guideline on procedural and administrative matters (including Direct Filling to Agency process) preparing/coordinating MSR when needed
  
  

Acts As Support For Belgium LOC For CTA Submission

• prepares the package related to the Clinical Trial Applications for Belgium CA (Ministry of Health R&D) gives the adequate support to the clinical team responsible for the submission and follow-up of the EC’s submission liaises to Belgium CA when needed
  

Ensures training of new employees and sharing best practices across GRA business and to external stakeholders.

Contributes to the monitoring of delivery performance, quality and lead times related to the different activities in the framework of the Development Delivery team.

Quality / Regulatory

Ensures adherence to legal constraints, local and international standards, Regulatory requirements and all GSK policies and procedures as applicable.

Risk / Compliance

Escalates any risk identified within the area of responsibility in order to secure CT business continuity at high quality standards.

Establishes, enforces and maintains high standards of documentation as well as an efficient and effective system of documentation so as to ensure compliance with GSK and regulatory requirements to satisfy any external audit for conformance.

Change and continuous improvement

Continuously anticipates potential improvements of the current processes while assuring compliance with the authorities’ guidance’s/legislation.

Contributes to change initiatives increasing the overall effective improvement of GSK R&D for CTA/IND.

Implements new processes to enhance business performance related to CTA/IND

Shares and integrates best practices within GSK R&D.

Why you?

Basic Skills And Qualifications

• Scientific master with project management/process orientation or equivalent by expertise
• A combination of a good CT expertise and project management skills.
• At least 5 years’ experience in coordination of Clinical Trial applications/IND.
• Good expertise in CTA/IND and associated regulations (regulatory dossier structure)
• Ability to coordinate projects also with external partners
• Good prioritization skills in function of business impact and criticality (project management)
• Fluency in spoken & written English.
• Good organizational, interpersonal and communication skills
• Flexibility and proactive thinking to meet business requests
• Rigor, quality mindset
• Team player
• Demonstrated skills for training and presentation
  
  

Preferred Skills And Qualifications

• Bio Engineer/Pharmacist with background in project management or equivalent by expertise
• Good knowledge of CTA/IND processes
• Skills in process optimization, training, and capacity to prioritize projects
  
  

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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