Senior Amendment Implementation Specialist

This is a fully remote position, open to applicants in Colombia.

📋 Description

• Executes amendment tasks within designated projects, ensuring that amendment deliverables fulfill customer expectations and meet contracted milestones by providing precise projections, report updates, and continuous risk assessments.

• Works collaboratively with various team members in a matrix environment to effectively deliver site activation for the assigned projects.

• May supervise site activation for designated projects in accordance with established timelines and quality standards.

• Aids in coordinating the flow of information between PPD teams, clients, and functional departments involved in site activation.

• Formulates recommended plans and guidelines for project implementation utilizing PPD tools.

• Monitors and evaluates project status to ensure successful progression and completion of all assigned projects, supplying metrics to upper management.

• Conducts risk identification and develops contingency plans.

• Partners with PPD teams to oversee all financial and contractual elements of the studies related to site activation.

• Collaborates with the team to implement appropriate controls to guarantee that project resources and expenses are in alignment with budgets, maintaining accountability to Global Project Management.

• Manages the technical and operational aspects of the site activation segment of the assigned projects, coordinating feasibility, site contracts, and country teams in a matrix environment, while overseeing the scope of work against timelines, costs, and quality.

• Engages with functional area leads to identify and assess critical issues affecting successful site activation, interprets data on complex matters, makes sound business decisions, and ensures the implementation of solutions.

• Cultivates customer relationships in alignment with assigned projects.

⛳️ Requirements

• Bachelor’s degree or an equivalent and relevant formal academic/vocational qualification.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary for the role (equivalent to 5+ years).

• Awareness of audit/inspection processes and relevant rules and guidance documents.

• In-depth knowledge of an application, system, or process.

• Strong organizational abilities and meticulous attention to detail, with a proven capacity to handle multiple tasks efficiently and effectively.

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

• Proficient analytical skills, capable of comprehending and analyzing data, tables, etc.

• Strong customer orientation.

• Flexibility to adjust workload priorities to meet evolving project timelines.

• Familiarity with ICH GCP, a solid understanding of applicable SOPs, and a good grasp of the clinical trial life cycle.

• Advanced proficiency in English (both verbal and written).

• Competent computer skills, proficient in MS Office (Word, Excel, PowerPoint), with the ability to learn and master all clinical trial database systems.

• Excellent collaboration and communication skills.

• Capable of working effectively in a team or independently as needed.

• Strong negotiation skills.

• Ability to collaborate efficiently with cross-functional teams.

• Consistently demonstrates knowledge of fundamental principles of cross-functional project management.

• Capable of identifying and addressing risks associated with contractual deliverables and providing suitable solutions.

• Displays a sound understanding of cross-cultural awareness and adapts appropriately.

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

• Demonstrates the ability to lead, liaise, and coordinate cross-functional project teams.

• Extensive knowledge and understanding of clinical development guidelines and directives.

🏝️ Benefits

• Reasonable accommodation for individuals with disabilities.

• Equal Opportunity Employer.