Data Management Team Lead at PAREXEL

Job description

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people whsucceed are the ones whmake the journey gfurther and faster every time. What if you had a partner tsupport you as you reach the next level in your professional path? A partner whbelieves a collaborative environment is key tachieving your goals? A partner whis dedicated tyour health and wellness syou can help make a difference in the lives of millions worldwide?

That’s PAREXEL. We’re a diverse team of professionals focused on one goal: getting treatments intthe hands of those whneed them most. Working together, the results we bring tour clients and the opportunities we bring tour team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

The Data Management Lead provides leadership and expertise in all aspects of Data Management and Database Programming. The Data Management Lead manages the delivery of all relevant data operations activities from database setup through database lock. General areas of responsibility include: coordination of the relevant Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact tensure that the contracted data deliverables are being met – specifically in terms of timeliness, financial management and quality.

May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned.

Key Accountabilities:

Accountability & Supporting Activities

• Provide leadership to ensure the project or program is completed within budget, schedule and according tcontract specifications. Ensure the project/program is progressing according tquality standards, SOPs, ICH and/or other guidelines tfulfill regulations (including oversight and maintenance of relevant data operations project documentation).
• Must manage time, and understand financials, maintain focus on quality, balancing deadlines with ensuring high quality output
• Thorough knowledge of numerous EDC systems (DataLabs, InForm, Rave.)
• Thorough knowledge of the eClinical suite and additional tools and systems that can be integrated with a particular EDC system (MyTrials, IVRS etc ) and Reporting functionality within the EDC system).
• Thorough knowledge of all DB set- up activities including but not limited tDatabase Configuration Specifications, Data Validation Specification, Protocol Deviation Specification, Data Cleaning Specification, SAE Reconciliation, UAT (User acceptance testing),

Knowledge and Experience:

• Substantial experience in clinical research
• Proven record of leading project and program teams in a technical/programming or data processing environment
• 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
• Competent in written and oral English

Skills:

• Leadership skills that include:
• Building and leading global (virtual) teams
• Ability twork effectively with and motivate virtual teams
• Ability tnegotiate and influence in order tachieve mutually beneficial results
• Proven problem solving skills
• Strong communication skills with a diplomatic approach
• Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention tdetail
• Effective time management in order tmeet 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 tgain trust and confidence with a variety of clients as well as within PAREXEL
• Excellent learning ability
• Managerial courage, resilience, and ability tadjust ta rapidly changing environment
• Excellent presentation skills
• Work with integrity
• Ability to travel as required

Business / operational skills that include:

• Strong customer focus, ability tinteract professionally within a client organization
• Understanding of PAREXEL project financial tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.
• Commitment to quality
• Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards
• Sound awareness of relevant regulations, including ICH-GCP, 21CRF11
• Excellent technical skills including but not limited tthe knowledge of Clinical Trial/Data Management Systems, PMED, IVRS