Lead DM (FSP)

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. InForm, Rave, Veeva, Data Labs, ClinBase.)
• 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.