Associate Principal Early Stage Development

Il y a 4 mois

Brussels, Belgique MSD Temps plein

The incumbent will be responsible for clinical trial operational execution of Early Stage Trials (also known as phase 1 trials) in Europe in close collaboration with the ESD Operations Lead. This includes overseeing operational efforts supporting multiple therapeutic areas, ensuring quality and ontime execution of all Translational Medicine (TMED) EU managed clinical trials and related deliverables. He/She will take initiative and connect with cross functional teams & collaborating departments in order to resolve upcoming operational issues and/or changes. He/She will also serve as point of escalation for issues within the projects and programs supported by TMED.

**Essential job functions may include but are not limited to the following**:
**1. Operational activities**
- Performing and Overseeing Operational support tasks, developping best practices & providing training on operational processes to Operations team ;
- Changing implementation agent for new or upated systems/data bases, processes, etc for the department ;
- Assisting in oversight of compliance and quality checks for operational functions (essential documents (eTMF), CTMS, site non-study specific training) ;
- Assisting in oversight of partners for task sourcing (essential documents, Source Document Verification, biological shipments consolidation). In this operational part of the role, the incumbent will have contacts internally within the department (EU and HQ), but also with other operational departments, such as Clinical Research Operations, IT.

**2. Clinical Grant Activities**
- Performing and overseeing study budgets/clinical trial agreements for consistency with study protocol ;
- Updating clinical and study planning databases ;
- ABC (anti-bribery + corruption checks) on all HCP (fact finding, workflows, tracking, renewals) + troubleshooting with compliance, technical services etc.;
- Clinical trial payments and payment tracking ;
- Financial disclosure (check need, track, process letters and documentation) ;
- Denied parties screening (DPS) ;
- Compliance checks ;
- Disclosure agreements ;
- Maintenance of trackers ;
- GMS (grants management system): enter and track payments, run reports execute payments in COMET (SAP), purchase orders as needed.

**3. Project Management-Portfolio and Business Level Projects**
- Leading project, team level activities (i.e. scope, timelines, issues, risks, etc.) and deliverables for process & business improvement initiatives ;
- Using appropriate project management tools and principles to effectively execute on assigned projects. Being effective at obtaining necessary project inputs if not readily available or known ;
- Establishing performance metrics for improvement initiatives measures/tracks and performing root cause analysis, mitigation and corrective activities on an ongoing basis ;
- Expert grasping of project linkages and which functions need to be consulted to get things done cross-functionally ;
- Managing ambiguity effectively - being able to define goals and scope and determine most effective pathways to achieve success.

**Education and Experience**
- Bachelor of Science : From 5-10 years of relevant work experience in clinical trial operations, preferably in phase I ;
- Master of Science or PhD : From 3 years of relevant work experience in clinical trial operations, preferably in phase I ;
- Fluent English and good knowledge of other European languages (preferably Dutch and French).

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R244293

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