R and D Senior Project Manager - Belgium The position is responsible for providing technical, operational and process leadership and support to the Global Clinical Pharmacology (GCP) Department
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The position is responsible for providing technical, operational and process leadership and support to the Global Clinical Pharmacology (GCP) Department as follows:
- Technology and Infrastructure: Serve as an SME for the identification, development and implementation of new technology and tools to ensure and enhance GCP department’s efficiency and effectiveness.
- Process: Develop, implement, manage, and actively ensure departmental compliance of cross-functional integrated GCP technology processes (i.e., SOP, GDL, WI, etc.). Actively monitor processes and operations to identify areas for process improvement and efficiency. Ensure streamlined cross-functional operations for shared processes.
This position ensures that all technical, operational and process activities of GCP are in compliance with regulatory and legal requirements and with company policies.
- Serve as one of the Technology Management point persons for technologies (maintenance and acquisition) within GCP.
- Lead the implementation of efficient solutions through procedures and technology processes within GCP.
- Lead the core software teams and working groups in the areas of clinical PK and pharmacometrics, which facilitate the development and implementation of technology (e.g., analysis tools, software, records management, etc.) for GCP. Ensure the operational execution of system tasks are completed on time, of high quality, and within budget.
- Take responsibility to manage and mentor individuals assigned to support GCP’s technology processes and infrastructure.
- Drive all technical, operational and process activities associated with secure global electronic data storage within GCP, including both short-term and long-term (Archival) storage.
- Lead system management and administration for designated systems within GCP:
- Support GCP personnel and customers in system setup, analysis and reporting:
- Provide functional advice, translate functional expectations into configuration in close cooperation with the users
- Defines design of required capabilities.
- Negotiate and implement data delivery with third parties.
- Contact with suppliers regarding the content of releases in close cooperation with the Business User SMEs, the Business Owner and IT, issue escalation.
- Responsible for systems administration activities such as support setup, configuration management, change management for minor and emergency changes, account management and library setup.
- Participates in validation activities. Is the Subject matter expert and responsible for compliance. Provides direction and actively contributes to developing, improving and implementing systems processes. Signals any violation or deviation to the immediate supervisor.
- Take the project lead role for technology projects.
- Drive the technical, operational and process activities associated with new analysis tools and software within GCP to ensure and enhance the department’s efficiency and effectiveness.
o Collect high level user requirements
o Functional vendor assessment of solutions
o Business case development and investment request definition
o Facilitate, and participate in full validation of tools prior to implementation.
- Manages appropriate GCP departmental technology documents (SOPs, GDLs, WIs, Forms, etc.) and ensures cross-functional alignment for all documents.
- Participate in ongoing process improvement efforts within the GCP organization to increase the department’s efficiency and effectiveness.
- Interface with the Business Support Group within GCP and JNJ Quality Assurance (QA) Department as a SME to facilitate audits of departmental technology procedures to ensure continued compliance.
Other Accountabilities & Tasks
- Deliver awareness communications and trainings to the department for updates to technical, operational and/or processes.
- When appropriate, represent the department on cross-functional committees related to GCP operations and processes, and liaise with external departments to ensure alignment with or implementation of these processes within GCP.
- Develops productive partnerships with business partners and vendors;
- Observes and promotes all regulatory requirements as defined per applicable regulations rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority;
- Complies with all training requirements necessary to perform the duties of the job;
- Assures that assigned (contractor) staff complies with the training requirements to perform the specific tasks.
Responsibility for Others
- Possibility to have direct responsibility for individual(s) assigned to support GCP technologies and infrastructure located globally. Authority.
Work from home: Not Allowed
International Travel: Yes
No. of Positions: 1
Skills and Expertise
Good to have
Desired Skills & Experience
A Master’s and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics.
- Advanced course work in technical systems plus continued education in technical disciplines is preferred.
- Additional certification is a plus.
- Minimal 8-10 years’ experience in business analysis, system administration and/or technology project management
Minimum Technical Knowledge and Skills
- Work experience in the domain of statistical packages, clinical pharmacokinetics and/or pharmacometrics systems.
- Understanding of the scientific operations associated with clinical pharmacology, clinical drug development, and overall pharmaceutical R&D process.
- Good working knowledge of guidelines on computerized systems used in clinical investigations
- Basic knowledge of the company IT systems and processes
- Good understanding of US and European regulatory processes and systems.
- Fluent in written and spoken English.
- General insight in information technology
- Skills in project management and process excellence, the ability to interpret and apply financial statements, and proficiency in the use of MS suite of software products.
- Knowledge of or experienced in IT support concepts
- Experience with software development methodologies and agile development methods.
- Insight and detailed knowledge of the use and validation of systems used in Clinical pharmacokinetics and pharmacometrics.
- Experience in R is a plus.
- Ability and willingness to travel regionally and globally (?10% of time).
- Ability and willingness to adjust work hours to facilitate global collaboration