. Coordinate the technical needs to create business and technical requirements documents . Coordinate project meetings, communicate with the team, internal/external partners and senior management . Participate in scoping, white-boarding sessions, est
Job Purpose: The Senior Manager is responsible for the oversight of a team of high-level contributors or a group of Managers. This includes ensuring successful delivery of his/her organization's project deliverables, on time with high quality. The Se
Skills :
VVV. Relevant experience in regulatory package preparation, compilation and submission to Health Authorities in various markets with focus on EU countries. . Working knowledge of EU regulatory procedures including adaptability to strict Health Author
. Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. . Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations,
. Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. . Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations,
Skills :
Key Accountabilities . Assume the ability to meet the requirements of a CDA I and II with a high degree of proficiency and autonomy . Act as an independent CDM Coordinator on complex or multiple projects, CMA/CDA Coordinator on smaller projects . Man
Skills :
The TMF Partnership Lead is responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor to ensure that the Trial Master File (TMF) deliverables (timeline, qual
The Principal Statistical Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors, and works independently to support various programing activities related to the analy
Skills :
Job Purpose: The Senior Data Support Specialist will serve as the Data Domain Steward for Regulatory & Access. This is a key role to be executed as part of the new data governance effort to clean, maintain, and report high quality data within Parexe
JOB DESCRIPTION Job Purpose: The Senior Manager Human Resources leads and manages a team of Manager(s) and or individual contributors and collaborates with the global human resource business partner community to build a culture, at the local/regiona
Reports To: Line Manager (Manager, Sr. Manager, Associate Director, Director) Directly Supervises: N/A Works Closely with: Project Leaders, Project Manager, Project Team Members, Finance External Relationships: Client, Independent Consultants Job Pur
Responsible for leading and supervising a team of Payroll specialists / Team leader in APAC. The Payroll team in APAC is responsible for processing multiple payrolls for different counties by ensuring pay is processed on time, accurately, and in comp
Knowledge and Experience: . Proven relevant experience in systems integration and implementation, or software development, or a related discipline . Demonstrated ability to liaise with multiple stakeholders . Experience with Microsoft Azure component
Skills :
The Senior Database Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various
Create, implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs w
. Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, includ
. Implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where a
The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and client
Signal Detection and Management : . Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc. . Responsible
Signal Detection and Management : . Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc. . Responsible
* Engineering and implementation of security technologies centric to Privileged Access security solutions. * Implementation & integration of PAM solutions (CyberArk skillset in Mandatory). * Experience in Identity & Access Management platform
. Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as development of predictive equations, survival analysis (including parametric methods), longitudinal data analysis, meta-analysis, mixed treatment c
The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and autonomy. Furthe
The Clinical Data Analyst III (CDA III) independently performs all clinical data validation activities on assigned projects, commensurate with experience and/or project role. Further responsibilities shall include providing technical expertise on dat
. Demonstrates full competence when conducting the following tasks: . Development of database build specifications . Development of data validation specifications . Test data creation & UAT . Performing/ leading functional QC activities and testing .