Summary: The CQV Documentation Specialist is responsible for creating, reviewing, and maintaining high-quality documentation that supports commissioning, qualification, and validation (CQV) activities for manufacturing process equipment i...
Summary: As a Clinical SAS Programmer, you will be responsible for attending multi-disciplinary team meetings to represent the programming function. You will create or review and approve programming plans at study and project levels, provi...
Job Description: The Sr. Regulatory Specialist is responsible for supporting client product and product development and regulatory activities to commercialize new digital products, including AI technologies. In this role, the Sr. Regulator...
Responsibilities: The Senior Clinical Data Manager provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity trials. The Senior ...
Responsibilities: Develop and implement qualification strategy for digital equipment in line with GMP and regulatory requirements. Create and execute qualification plans/protocols, ensuring proper documentation and compliance. Conduct r...
Responsibilities: Providing statistical programming support to generate tables, listings, and figures for assigned projects. Demonstrating proficiency in CDISC, SDTM, and ADaM to support various submission activities, including IA, CSR, ...
Roles & Responsibilities: Lab CSV consultant needed. Working on standard lab equipment systems, temp monitoring systems will be the first but will also include HPLC, GC and various other lab equipment. helping define a program and plan f...
Responsibilities: Under the direction of the applicable management, the Clinical Data Manager (CDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data manag...
Responsibilities: Ensure departmental or functional training plans in place and appropriate. Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time del...
Responsibilities: Represent Data Management in study team meetings, providing metrics and guidance on data-related issues. Oversee Data Management activities from study start-up to close-out. Develop and manage study timelines and ensur...
Job Description: As Qualification Specialist in the Equipment Integration team, you are responsible for caring about the GMP requirements. The team is responsible for transferring existing Lab Equipment form Spark Network to Roche Connec...
Job Description: Working with the Biometrics staff, the candidate will provide programming support for Phase 1 to Phase 3 studies. Providing timely support to the project team on all statistical programming matters according to the projec...
Responsibilities: Collect, enter, and manage clinical trial data using electronic data capture (EDC) systems. Perform data validation and query management to ensure data quality and compliance with study protocols. Assist in the develop...
Responsibilities: Attending multi-disciplinary team meetings, representing the programming function. Create or review and approve programming plans at study and project level. Provide input on key study-related documents produced by oth...