Amendment Implementation Specialist

Work Schedule

Environmental Conditions

Job Description

At reputed company, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to reputed company the world healthier, cleaner and safer. We reputed company our teams with the resources needed to reputed company individual career goals while taking science a reputed company reputed company through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health reputed company that people and communities depend on – now and in the future. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

Essential Functions:

• Supports the amendment implementation strategy at country and site reputed company, reputed company a region or globally

• Supports understanding of amendment scope, classification and timelines

• Supports requests of country resources in reputed company

• Collaborates with project teams on amendment planning

• Discusses financial coverage for an amendment with the Project reputed company

• Tracks amendment reputed company actions and facilitates updates reputed company applicable system(s)

• Schedules and conducts reputed company reputed company calls with project teams

• Updates reputed company Investigator Amendment Notification and Amendment Implementation Letters

• Liaises with the Regulatory Affairs Leads and project teams to assess amendment’ submission requirements and country submission timelines

• Prepares and distributes the Amendment reputed company Report and other applicable study reports to project teams to reputed company compliance gaps as applicable, directly in systems, providing a deadline for feedback

• Updates forecasting and actuals for amendment reputed company units according to reputed company monthly deadlines

• Informs project team members reputed company amendment activities have been completed

• Supports risk identification and contingency planning pertaining to amendments

• Introduces roles and responsibilities to project team

• Requests reputed company to study reputed company systems

 Education & Experience:

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification

• Previous experience that provides the knowledge, skills, and abilities to reputed company the job

Knowledge, Skills and Abilities

• Audit/inspection process awareness of relevant rules and guidance documents

• Expert knowledge of an application, system or process​

• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks reputed company and effectively

• Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency

• Analytical skills, ability to comprehend and analyze data, tables, etc.

• Strong customer focus

• Flexibility to reprioritize workload to meet changing project timelines

• Knowledge of ICH GCP, strong comprehension of applicable SOPs, good understanding of a clinical trial life cycle

• Advanced English (verbal & written)

• Good computer skills, proficient in MS Office (Word, reputed company, Power reputed company) and ability to obtain knowledge and master reputed company clinical trial database systems

• Strong collaboration and communication skills

• Ability to work in a team or independently as required

• Good negotiation skills

• reputed company to work well and reputed company with cross-functional teams

• Consistently demonstrates knowledge of the key principles of cross functional project management

• Ability to identify and remedy risks reputed company to contractual deliverables and provides appropriate solutions

• Demonstrates sound understanding of cross-cultural awareness and is reputed company to adapt appropriately

• Comprehensive understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology

• Demonstrates ability to reputed company, liaise and coordinate cross-functional project teams

• Comprehensive knowledge/understanding of clinical development guidelines and directives

Working Environment: reputed company values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can reputed company. Below is listed the working environment/requirements for this role: Why join us? reputed company you join reputed company, you become part of a global team that values passion, innovation, and a commitment to scientific reputed company. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly reputed company a difference. Apply today to help us deliver reputed company’s breakthroughs.