Job Purpose:

The Manager is responsible for the oversight of a team of high-level contributors or a group of junior managers (Associate Managers). This includes ensuring successful delivery of his/her organization’s project deliverables, on time with high quality. The Manager is responsible to resource client projects with suitably developed professionals and to retain and develop these professionals within Parexel. The Manager is responsible to promote new business by participating in project bids and client presentations, as appropriate. The Manager is responsible to provide expertise and consultation to project teams. The Manager is an experienced leader capable of working independently, under supervision of the Senior Manager, Associate Director, Director, or Senior Director.

Key Accountabilities:

Operational Execution:

• Manage and oversee departmental activities including appropriate resourcing of staff, staff assignments, quality control and timely delivery of project deliverables.
• Monitor performance by having interactions with Lead Clinical Data Engineers, Database Programmers, SPL, DML, and BL
• Check quality of team deliverables and appropriate remedial action.
• Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of activities.
• Support in data collection for KPIs, Metrics and maintenance of
• Metrics Inventory.
• Produce Monthly/Quarterly metrics/Dashboard as assigned.
• Drive initiatives that require cross functional collaborations.
• Undertake the full range of duties relevant to the management and development CDE Leads to ensure their performance meets or exceeds business or own goals and objectives.
• Demonstrate strong leadership within department, function, or location. This includes taking an active role in department, functional or location activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate.

General Activities:

• Train, mentor and allocate team members according to their ability.
• Provide technical support to team members to ensure that they have the required knowledge to fulfill their duties.
• Meet and aim to exceed client expectations by recruiting, retaining, and developing a skilled, experienced, and motivated team.
• Maintain an agreed level of productivity/billability and staff turnover.
• Serve as an ongoing liaison with Lead Data Engineers, Programmers, DML, BL, PS and PL, Sponsor, and management regarding performance of direct reports.
• Manage and develop the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.
• Maintain a positive, results orientated work environment, building partnerships, and modeling teamwork, communicating to the team in an open, balanced, and objective manner.
• Participate in formal staff review processes e.g., performance and salary reviews to corporate standards and timescales.
• Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements and Parexel WSOPs.
• Participate in Parexel and department system/standards improvement activities.
• Complete routine administrative tasks in a timely manner (e.g., timesheets, metrics, travel expense claims.
• Departmental or Project tasks as assigned.
• Participate in and contribute to project bids, including client presentations.
• Act as a System Owner where required.

Skills:

Leadership skills that include:

• Building and leading global (virtual) teams
• Demonstrated ability to successfully manage a full workload across multiple projects
• Outstanding negotiation and organizational skills
• Excellent analytical and problem-solving skills
• Strong communication skills with a diplomatic approach
• Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
• Effective time management to meet objectives
• Ability to conduct root cause analysis in business problem solving and process improvement development
• Ability to make appropriate decisions in ambiguous situations

Personal skills that include:

• Excellent interpersonal, oral, and written communication skills
• Ability to gain trust and confidence with a variety of clients as well as within Parexel
• Excellent learning ability
• Managerial courage, resilience, and ability to adjust to a rapidly changing environment
• Excellent presentation skills
• Work with integrity
• Ability to travel as required

Business / operational skills that include:

• Commitment to quality
• Understanding of Global Data Operations tasks, specifically within Data Management and Data Engineering, regulatory requirements, and relevant data standards

Language Skills:

• Competent in written and oral English and local language

Technical skills that include:

• Comprehensive knowledge of relevant software (SAS, SQL, any Data management workbench) and systems.
• Database understanding (Inform, Rave etc.)
• Documentation platforms (PMED, Veeva Vault etc.)

Knowledge and Experience:

• Significant work experience in similar position, preferably in clinical programming
• Acted in a leadership role in his/her area of expertise
• Proven record of leading project and program teams
• Strong understanding of cross functional activities
• Strong customer service focus
• Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures

Education:

• Bachelor’s degree and / or other qualifications in a science or industry related discipline

Responsibilities:

• The Principal Clinical Data Engineer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors.
• The Principal Data Engineer will fill the lead role on projects; liaise with sponsors, Data Management Leads and other functional areas as required.
• Accountable for first time quality on all deliverables.
• Actively assume activities on a project as required.
• Monitor project resourcing and identify changes in scope.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work to ensure first- time quality.
• Provide technical support and advice to the internal team.
• Coordinate and lead a programming team to successful completion of a study within given timelines
• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance.
• Lead or drive global initiatives – Develop, improve and implement project specific tools, including, but not
• limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies

Skills:

• Excellent ability to lead and collaborate with global teams and work independently. 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
• 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
• Advanced presentation skills
• Time management and prioritization 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 relative to Key Accountabilities in Job Description
• Good business awareness/business development skills (including financial awareness).
• Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
• Demonstrate commitment to refine quality processes
• Demonstrated application of CRS concepts to achieve best practice and promote continuous
• improvement.
• Excellent analytical skills.
• Tenacity to work in an innovative environment.
• Ability to travel as required
• Written and oral fluency in English

Knowledge and Experience:

• Should have working experience as DAS (Data Acquisition Specialist)
• Experience on
• Set up of conformance checks for Test/Prod data when the study is on ‘Go live’.
• Draft FFS/Blueprint for non-CRF data collected for a study.
• Work closely with study team and vendor to set up IXRS UAT to configure Batch-uploader.
• Programming of Reconciliation to ensure the non-CRF data is without any discrepancies.
• Programming of offline listings to ensure EDC data and Vendor data doesn’t have any mismatches, along with CRF listings.
• Programming of QASH checks to compare inventory file received from vendor against RAVE data to find any discrepancies.

Education:

• Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.

Responsibilities:

• The Senior Clinical Data Engineer will be recognized as a subject matter expert, providing technical
• support and expert advice to internal and external sponsors.
• The Senior Data Engineer will fill the lead role on projects; liaise with sponsors, Data Management Leads and other functional areas as required.
• Accountable for first time quality on all deliverables.
• Actively assume activities on a project as required.
• Monitor project resourcing and identify changes in scope.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work to ensure first- time quality.
• Provide technical support and advice to the internal team.
• Coordinate and lead a programming team to successful completion of a study within given timelines
• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance.
• Lead or drive global initiatives – Develop, improve and implement project specific tools, including, but not
• limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies

Skills:

• Excellent ability to lead and collaborate with global teams and work independently. 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
• 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
• Advanced presentation skills
• Time management and prioritization 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 relative to Key Accountabilities in Job Description
• Good business awareness/business development skills (including financial awareness).
• Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
• Demonstrate commitment to refine quality processes
• Demonstrated application of CRS concepts to achieve best practice and promote continuous
• improvement.
• Excellent analytical skills.
• Tenacity to work in an innovative environment.
• Ability to travel as required
• Written and oral fluency in English

Knowledge and Experience:

• Should have working experience as DAS (Data Acquisition Specialist)
• Experience on
• Set up of conformance checks for Test/Prod data when the study is on ‘Go live’.
• Draft FFS/Blueprint for non-CRF data collected for a study.
• Work closely with study team and vendor to set up IXRS UAT to configure Batch-uploader.
• Programming of Reconciliation to ensure the non-CRF data is without any discrepancies.
• Programming of offline listings to ensure EDC data and Vendor data doesn’t have any mismatches, along with CRF listings.
• Programming of QASH checks to compare inventory file received from vendor against RAVE data to find any discrepancies.

Education:

• Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.

#LI-REMOTE

• Preferred to have hands-on working experience at a high-level Architecture or Data Science
• Must have knowledge of Azure along with provisioning, configuring, and developing solutions in ADL, ADF, ADW, etc.
• Should have an in-depth knowledge of database structure principles
• Must have hands-on working experience using MS SQL Server, Oracle, or RDBMS platform
• Good to have knowledge of distributed data processing of big data or streaming pipelines
• Able to construct data science, research machine learning, and build production pipelines
• Preferred to have familiarity with data visualization tools such as PowerBI, Tableau, etc.
• Good to have knowledge of Data Modeling and Analytics
• Participate in the analysis, design, and development of systems that includes logical and physical data modeling, database design, database creation, and evaluation of data and information requirements for new applications and reports
• Conduct technical discovery, identifying pain points, business, and technical requirements
• Advanced experience in data visualization tools with a grasp of effective data modeling and visualization practices
• Preferred to have good interpersonal and problem-solving skills
• Must be self-motivated and able to work with minimal supervision
• Should have the ability to prioritize, multi-task, and execute tasks
• Good communication skills with the ability to work in large teams and interact with technical teams