PAREXEL International

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small. In retu

As one of the world's leading global clinical research organizations (CRO), we provide the clinical development capabilities and integrated consulting expertise it takes to streamline development every step of the way — faster and more cost-effectively.

Demonstrated computer proficiency including advanced knowledge of Microsoft applications Excel Word etc as well as problem solving and analytical skills Strong communication interpersonal organizational and time management skills

Develop knowledge of SAS and processes/procedures within other Parexel functional areas Develop knowledge of clinical trial process Check own work in an ongoing way to ensure first-time quality Work on dummy datasets, tables, listings and figures Work on some new statistical methods used in clinical trials Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and inte

Candidate should have minimum 6 months to 1 years of relevant experience in Software Testing. Good demonstrated experience in developing UAT strategy, writing and executing test scripts and working in the Registration Data domain. Must have strong knowledge of Regulatory Affairs/ Operations domain and regulatory requirements.High degree of technical knowledge and testing and validation skills are r

PAREXEL is hiring a Drug Safety Physician in Hyderabad. If you have an MBBS/MD and a passion for drug safety, apply now

We are currently looking for Regulatory Affairs Professionals experienced in Clinical Trail Applications (CTAs) under EU-CTR directive. You can join us or our client dedicated projects and act as a Regulatory Affairs Consultant or Regulatory Affairs Senior Associate. This role can be based in either UK or UE (home/office based). In this role you will provide leadership in all regulatory and s

​Clinical Trial Protocol Specialist • The Clinical Trial Protocol Specialist will research, create, and edit clinical trial protocols as well as provide expert support for protocol development. • Operates as a lead medical writer or as a Subject Matter Expert (SME) to support Medical Writers and Clinical Trial Services management, as well as other Parexel functions. • Facilitates process improve

The Identity Access and Management (IAM) team within the Information Security Office, provides subject matter expertise, and associated security services to business divisions across the enterprise. As a member of the IAM Operations team, you will provide timely Infosec solutions to end users, analyze provisioning workflows, provide custom access reports, implement / update LDAP / JDBC application

The Identity Access and Management (IAM) team within the Information Security Office, provides subject matter expertise, and associated security services to business divisions across the enterprise. As a member of the IAM Operations team, you will provide timely Infosec solutions to end users, analyze provisioning workflows, provide custom access reports, implement / update LDAP / JDBC application

TMF Support • Collaborates with the TMF Inspection Readiness Specialist to plan and execute assigned tasks. • Maintains overview of the agreed planning, proactively providing status updates and notifying trends to the study team and TMF IR Specialist. • Stays flexible and always looks for proactive, responsible solutions to ensure client satisfaction. • Provides feed-back to PS/FL Super Users i

Hi, We are hiring for Sr CDA role with 3 years of minimum experience into Project management/ TL/ Data manager role. • Job Descriptio • Clinical Data Manageme v Manage all phases of data management activities from study start up to database close, which may incl de: v Development of database build specifica ions v Development of data validation specific tions v Test data creatio & UAT

Job Description The Senior Statistical Programmer (SSP) provides technical SAS expertise for the conduct of clinical trials in support of various programming activities related to the analysis and reporting of clinical study data. General responsibility include • Minimum Work Experien • · 4 to 9 years of SAS programming experience in clinical do in. • ll* • Use efficient programming techniq

The role of the Clinical Data Coder I (CDC I) is to perform assigned tasks or activities in clinical data coding. Activities may include coding of clinical data, generation and integration of queries, and running of reports under supervision of senior coding staff and/or line manager. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH

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 Manage all phases of data management activities from study start up to database close Direct team members in daily activities Define and monitors metrics and modifies plan accor

As a member of Parexel’s Statistical Programming group, you will be heavily involved in leading trials to successful completion, working in close collaboration with sponsor teams, and Parexel teams in differing locations. Depending on your career goals, you will be provided the opportunity to be exposed to a variety of different sponsors, products and therapeutic areas, or choose to focus your care

Conduct set-up and support activities associated with the Parexel safety database (and associated systems) including but not limited to: New study set-up Periodic report configuration and generation Ad-hoc report configuration and generation Expedited report rule configuration End-user support Provide support and contribute to the planning and delivery of the handover of the safety database f

As a Biostatistician at Parexel you’ll work on a variety of projects, while collaborating with our global team of experts. You’ll be able to develop your statistical skills, gain exposure to multiple therapeutic areas, become involved in business development activities, and have the opportunity to grow and develop your career within a flexible working environment. You’ll also contribute to resea

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. A

The Clinical Supply Specialist (CSS) will support the Clinical Supply Leader with the development and applying the study specific supply chain strategy incl. the sourcing and distribution strategy and the technical management for Clinical Trial Supply and Logistics projects. The CSS supports the Clinical Trial Supply and Logistics teams by applying and executing supply chain to achieve client sa

The Data Management Lead ll provides leadership and expertise in all aspects of Data Management. Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management’s single point of contact to

Collaborate and communicate within the Global study team matrixto provide study start up strategy, input to milestone development, and alignment of operational targets to ensure timely delivery of study start up activities. Participate in client meetings with respect to study start up, including endorsement of the SSU Operational Targets & mitigation of delivery risks, establishing client expect

PK Analyst is responsible for the derivation of Pharmacokinetic (PK), and Pharmacodynamic (PD) parameters including the programming and validation of NONMEM datasets, PK/PD derived datasets and tables, listings, figures, and statistical appendices. The Senior PK Analyst also provides support to other analysts. This includes programming assistance, query resolution, mentoring and training. Key Acco

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small. In retu

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. A

Prepare draft contract documents, including Start-up Agreements, Work Orders and Change Orders, from Parexel templates per guidance provided by the assigned Contract Manager or Line Manager, and in conjunction with relevant departments Amend project budgets as required Direct client interaction with established contacts per guidance provided by the assigned Contract Manager or Line Manager Provi