Job Vacancies at Parexel

Summary of the Role:-

Develop, analyze, document, and continuously improve controlled processes as per current formats/standards which is a key component of the Quality Management System (QMS). Publish controlled processes in Parexel’s Electronic Document Management System. Plays a key role in ensuring that up-to-date CDs are always available to Parexel employees. This includes coordination of CD lifecycle procedures and maintenance of the CD Library. Support the management of process deviations which includes consultation, publishing, management of deviation lifecycle and archival. Updating trackers & managing projects according to specific agreed timelines.

Knowledge and Experience:

• 1 to 3 years work experience.
• Experience in Clinical Research field (pharmaceutical industry or CRO) or other pertinent experience in the areas of QMS support preferred.
• Knowledge of Controlled Document management, process improvement or equivalent role in industry preferred.
• Knowledge of GxP compliance as required.
• Some experience in Quality Management preferred.
• Experience working in a global environment preferred.

Education:

• Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred or equivalent qualification or clinical research experience.

Skills:

• Excellent interpersonal, verbal and written communication skills.
• Customer focused approach to work.
• A flexible attitude with respect to work assignments and new learning.
• Ability to manage and prioritize tasks efficiently and accurately.
• Willingness to work in a matrix environment and to value the importance of teamwork.
• Understanding analytics and basic statistics, logic design concepts.
• Understanding structured process analysis, improvement methodologies, business process modeling and an understanding of business workflows (Lean Six Sigma skills).
• Understanding of Quality Management System, Good Clinical Practice (GCP), FDA regulations, as well as current industry trends.
• Ability to lead projects and teams.
• Strong ability to analyze and interpret data.
• Good time management, multitasking and troubleshooting.
• Attention to detail and advanced organizational skills.
• Ability to work independently and take ownership of and responsibility for work assigned.
• IT literate – Experience with Microsoft based applications and a general knowledge of PC functions.
• Culturally aware and ability to think and work globally.
• Willing and able to travel as required – local or international.
• English proficiency (written and oral English).

Key Accountabilities

• Works with staff at all levels in operational/business units to develop, analyze, document, determine process related issues (needs to address operational performance requirements) and continuously improve controlled processes as per required standards/templates.
• Publish controlled processes in Parexel’s Electronic Document Management System which includes management of CD e-signature workflow.
• Educate and advise process owners on process improvement opportunities using methodology, data and fact   and utilize recognized process improvement methodologies to eliminate waste/rework as well as break through improving business performance.
• Monitor/coordinate Controlled Document lifecycle and maintenance of the Controlled Documents Library.
• Support provisioning of external parties/clients to Parexel’s Controlled  Documents as appropriate.
• Oversee the Controlled Documents tools & trackers which supports the business as required.
• Oversee the allocation of Controlled Document numbering as required. Support the management of process deviations which includes consultation, publishing, management of deviation lifecycle and archival.
• Assist cross-functional teams with the integration of acquired companies into Parexel’s QMS, as required.
• Database, tools, and tracker maintenance.
• Administrative work (filing, copying, formatting, editing, proofreading).
• Managing Stakeholder-approved CDs through the BPM process, including Quality Control (QC), e-signature workflow, Master Binder administration.
• Lead improvement projects in own group to facilitate continuous growth and high-quality support to the rest of the organization, as required.
• Supporting maintenance of internal & external Pulse Pages.
• Work with business/functional units to determine analytical tools needed   for process analysis and improvement projects.
• Drive projects in-order to improve process efficiency, as required.

go to method of application »

About the job:

• The Clinical Data Engineer 1 works with close supervision to support various activities related to electronic data, and/or the application of computer and communication technologies. General areas of responsibility also include: Aggregating applicable data from all sources and devices, managing external data, programming offline listings, trend analysis, data review, data transfers.

What You'll Do At Parexel:

Manage Projects &Technology

• Programming and setup of Import procedures to allow the ingestion of data either using SAS or alternative technology (e.g. “Workbench”)
• Programming of reconciliation checks to ensure appropriate transfer of data.
• Programming of offline listings and custom reports to allow better insights to all external data.
• Aggrege data across all sources.
• Handling Missing Values, reading raw data files, creating data structures, handling programming errors, accessing, and managing data, appending and concatenating SAS datasets.

Documentation

• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams

Ideal candidate will possess:

• University degree in a relevant discipline.
• Fluent English
• Basic experience in at least one of the following (e.g. SQL, SAS, R).
• Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
• Experience in clinical research industry or similar field is required.

go to method of application »

Summary of the role KPI's:-

• The Senior Data Management Lead provides leadership and expertise in all aspects of Data Management. Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness, financial management and quality.
• The Senior Data Management Lead can competently and independently lead large, complex projects and/or programs with little to no guidance from their Line Manager and/or Subject Matter Experts. Senior DMLs may act as a mentor for ADMLs, DMLs and other Senior DML peers.
• May act as Project Leader for projects, involving only Global Data Operations services.

Essential Knowledge and Experience Required:

•  Substantial experience in clinical research industry
•  Proven record of leading project and program teams within Data Management team
•  Advanced understanding and application of Parexel tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.
•  In-depth understanding of Clinical Study Team roles outside of Data Management
•  Full understanding and application of ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
•  Awareness of SDTM/CDISC/CDASH standards
•  Advanced technical skills including, but not limited to the knowledge of Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products

Skills:

•  Excellent ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
•  Excellent negotiation skills and ability to influence in order to achieve mutually beneficial results
•  Excellent interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
•  Learning ability and knowledge sharing approach; swift understanding of technologies and new processes
•  A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments
•  Advanced presentation skills
•  Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust
•  Commitment to first-time quality, including a methodical and accurate approach to work activities
•  Time management and organizational skills, in order to meet objectives and timelines
•  Highly developed problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses
•  Ownership and accountability for Key Accountabilities in Job Description
•  Ability to travel as required
•  Written and oral fluency in English

Education:

•  Bachelor’s degree and / or other qualifications in a science or clinical related industry
•  Certification or involvement in a professional society or organization is recommended