Jobs at PAREXEL

Responsibilities

• Lead a large clinical study or a series of related studies with minimum guidance.
• Represents Data Management on the CTWG for assigned studies.
• Provide mentoring and training to lower-level Data Management staff assigned to your studies.
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Be able to perform a thoroughly detailed review of eCRF data requirements.
• Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
• Lead the development of data edit check specifications and data listings.
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members.
• Develop or lead the development of the Data Management Plan for a clinical study.
• Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.
• Provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed.
• Perform reconciliation of header data from external data sources against the clinical database.
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines.
• Lead database upgrades/migrations including performing User Acceptance Testing.
• Maintain study workbooks and data management files.
• Perform database lock and freeze activities per company SOPs.
• Participate in regular team meetings and provide input when appropriate.
• Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents.
• Contribute to a professional working environment including the application of the sponsor’s Code of Business Conduct and Ethics.
• Assist with the training of new employees and/or contractors.

Here are a few requirements specific to this advertised role.

• Bachelor’s Degree required, preferably in the scientific/healthcare field.
• Proven leadership experience.
• Good project management skills and a proven ability to multitask.
• At least five years’ or preferably up to 8 years' experience, in Data Management for the pharmaceutical/biotechnology industry.
• Understanding of the scope and focus of Phase I – IV clinical studies, and a proven ability to perform some of the core Data Management tasks and interact with vendors. A high level of Phase I experience is essential.
• A comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Strong English language written and verbal communication skills.
• Able to travel to meetings or training seminars on occasion.
• Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.

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Responsibilities

• Lead a large clinical study or a series of related studies with minimum guidance.
• Represents Data Management on the CTWG for assigned studies.
• Provide mentoring and training to lower-level Data Management staff assigned to your studies.
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Be able to perform a thoroughly detailed review of eCRF data requirements.
• Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
• Lead the development of data edit check specifications and data listings.
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members.
• Develop or lead the development of the Data Management Plan for a clinical study.
• Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.
• Provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed.
• Perform reconciliation of header data from external data sources against the clinical database.
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines.
• Lead database upgrades/migrations including performing User Acceptance Testing.
• Maintain study workbooks and data management files.
• Perform database lock and freeze activities per company SOPs.
• Participate in regular team meetings and provide input when appropriate.
• Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents.
• Contribute to a professional working environment including the application of the sponsor’s Code of Business Conduct and Ethics.
• Assist with the training of new employees and/or contractors.

Here are a few requirements specific to this advertised role.

• Bachelor’s Degree required, preferably in the scientific/healthcare field.
• Proven leadership experience.
• Good project management skills and a proven ability to multitask.
• At least five years’ or preferably up to 8 years' experience, in Data Management for the pharmaceutical/biotechnology industry.
• Understanding of the scope and focus of Phase I – IV clinical studies, and a proven ability to perform some of the core Data Management tasks and interact with vendors.
• A comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Strong English language written and verbal communication skills.
• Able to travel to meetings or training seminars on occasion.
• Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.
• Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.

go to method of application »

What You'll Do At Parexel:

• Deliver best value and high-quality service working on client system and following client processes
• Work closely with client teams and Parexel colleagues in global environment
• Specialize in one of the following therapeutic area: hematology/oncology/cell therapy
• Use SAS programming to produce derived datasets (ADaM), tables, figures, and data listings of varying complexity
• Develop and QC derived dataset specifications and other process supporting documents
• Ensure all work maintains complete traceability and regulatory compliance
• Participate and contribute to knowledge-sharing sessions with programming community

Requirements:

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences
• Minimum 3 years of SAS programming experience in clinical research
• Proficiency in SAS Base, SAS/STAT, SAS/GRAPH, and SAS macros
• Strong understanding of CDISC standards
• Knowledge of statistical terminology, clinical tests, and protocol designs
• Excellent attention to detail with a focus on quality
• Strong written and verbal English communication skills