Principal Project Lead, Sdtm

il y a 4 semaines

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre

**Posted Date**: Mar 9 2023

Job Purpose

The purpose of this position is responsible for operational delivery of a Therapy Area portfolio in terms of development, validation, and review of study and SDTM programs. This role will be a technical expert and technical owner for the delivery. This role mentors SDTM team member(s) and acts as Subject Matter Expert.

Key Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

- Provide innovative solutions, developing and delivering quality data conversion process as well as ensure operational delivery across multiple therapeutic area.
- Lead, develop, validate and review study & standard programs/macros (Including SAS, CQL, PL/SQL, SPOTFIRE, RProgramming, Python) that support standard and study-level conversion of clinical trial data.
- Responsible for review, development, and validation of aCRF, SDTM mapping, define.xml, Pinnacle 21, SDRG, data Listings and checks for various standard or specific studies.
- Lead the requirement gathering, development of specifications, Validation plans and performing end to end validation of Standard/Study macros.
- Expert knowledge in defensive programming techniques.
- Support the programmers in troubleshooting and debugging of complex standard and study programs/macros.
- Act as a coach and mentor to develop technical competencies.
- For complex programs & tools, oversee & coordinate a group of Programming Leads.
- Excellent in Project Management for end-to-end study (CDM To Submission) and ensure deliverable are met on time.
- Provide input to CAPA and response to audit findings.
- Identity and implement the area of improvement in the existing process and bring futuristic innovative solutions.
- Lead and own solutions for automation. - Be a technical developer and reviewer for tools and programs.
- Act as a primary point of contact for external stakeholders (Data Management, Data Acquisition, Clinical Programming etc.) w.r.t programming activities (SDTM / CQL / SAS Programming).
- Overseeing FSP studies and review their work. - Ability to effectively communicate with the stakeholders of progress and challenges with deliverables. - Able to conduct technical interviews. - Establish and maintain effective working relationships with partners and stakeholders.
- Adhere to quality metrics and assurance. - Compliant with departmental expected policies and procedures.
- Anticipates and discusses action items around process with Reporting Manager.
- Manage potential risk identification and mitigation in terms of process. ;
- Exploring and visualizing data to gain an understanding and analyze the patterns and trends in data distribution that could impact the process and performance.
- Ability to analyze the ML algorithms that could be used to solve a given problem and ranking them by their success probability.

**_ Why you?_**:
**Qualifications**:
We are looking for professionals with these required skills to achieve our goals:

- Bachelor's Degree in computer/Math/Statistics/Applied Science or above
- Life-science or related medical/clinical area with 8 - 10 years of programming experience
- Appropriate line management/supervisory experience
- Considerable experience in delivering quality data conversion delivery within the organization.
- Understanding different data conversion requirements across different TA and assets
- People leadership experience with direct/indirect reporting
- Experience with diverse TA portfolio delivery.
- CDISC - CDASH, SDTM and ADaM knowledge.

Language skills:

- Fluent English language (spoken and written)
- French language and Italian language known is a plus

Soft skills:

- Strong matrix leadership skills
- Effective communication and presentations skills
- Team spirit - Ability to facilitate interfaces within extended network
- Proven experience in negotiating and influencing at various levels of the organization in a matrix environment.
- Attention to detail, conscientious and accurate
- Good organizational, planning and time management skills - Proven ability to prioritize and multi-task
- Experienced in leading improvement initiatives from inception through to completion involving both multi-disciplinary and geographically remote partners.
- Good analytical, problem solving and project delivery skills

Hard skills:

- Prior knowledge of SDTM conversion and good understanding about Data Management and study build process
- Extensive knowledge of drug development process and working knowledge of GCP
- Knowledge on regulatory submissions (JPMA/PMDA) and hands-on knowledge on programming data conversions.
- Experience with CRF automation process for SDTM annotations.
- Experience review and co-ordination of SDTM review on outsourced studies and understanding SDTM harmonization for pooled analysis.
- Experience converting structured and unstructured data from vario

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