Lead DM (FSP)

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities : Data Validation (cleaning) Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), e.

g. query management, manual/SAS listing reviews and external vendor data reconciliation. Highlight issues/risks to delivery by understanding interdependencies - support mitigations as part of Risk Management Plan. Data Management Documents/Plans (Trial Master File) Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.

Study Start-Up Activities and User Acceptance Testing (UAT) Lead/perform user acceptance testing on clinical database setups. Review protocols and EDC Entry Screens if required. Provide input on the data management timelines and coordinate the DM operational activities during database set up. Data Tracking and Entry Track and review CRFs.

Support data entry where required. Project Quality Management & Compliance Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines. Perform/Lead functional QC activities on databases and/or patient data, as per business needs. Training Maintain training compliance as per Job Roles assigned, including On-the-Job training.

Address training needs, as per Development Goal/s identified. Provide relevant on-the-job training to staff and project teams as appropriate. Act as Mentor for other clinical data analysts. Act as Subject Matter Expert regarding DM operational tasks/tools/processes/systems. Process/Project Improvement 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.

Project Finance & Resource Support Determine root cause of operations-related project variance in a timely manner, based on DM operational metrics/labor hour reports - provide input on Changes in Scope needed. Skills: Ability to lead and collaborate with global teams - ability to coordinate & prioritize tasks for the DM operational team when in the Primary CDA role.

Ability to independently interact with Sponsor liaison to discuss data issues/project data validation requirements, as needed. Negotiation skills and ability to influence in order to achieve mutually beneficial results. Strong problem-solving skills and logical reasoning, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses.

Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail). Time management and prioritization skills with a sense of urgency - in order to meet objectives. Strong interpersonal, oral and written communication skills - using concise phrasing tailored for the audience with a diplomatic approach.

Basic presentation skills. Strong 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 technical environments. Evidence of accountability relative to Key Accountabilities in Job Description.

Written and oral fluency in English. Knowledge and Experience : Advanced technical aptitude with awareness/potential prior experience in Microsoft Office Products (strong computer skills). Advanced understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock) Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific procedures Strong knowledge of Clinical Data Management Systems and proficiency in at least one system (e.

g. In. Form, Rave, Veeva, Data Labs, Clin. Base.) Good understanding of Clinical Study Team roles within Data Management - awareness of DML activities e.g.: budget reviews, resource forecast, etc. Experience in clinical research industry Good knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG) Advanced knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out Advanced knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation Basic knowledge of SAS (programmed listings) Basic knowledge of Data standards (CDISC) Basic understanding/willingness to learn of financial principles/drivers for management of DM project financials with regards to forecasting and scope of work.

Experience of leading virtual Data Management operational team to perform DB set up, data cleaning activities Education: Bachelor’s degree and / or other medical qualifications or relevant industry experience.