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Project Specialist - FSP

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

India

Offer summary

Qualifications:

Bachelor's degree or equivalent experience, 2+ years relevant work experience, Knowledge of ICH GCP and SOPs, Strong organizational and analytical skills, Advanced English proficiency required.

Key responsabilities:

Coordinate and lead operations metrics for efficiency
Support study teams in maintaining audit readiness
Conduct risk assessments to ensure compliance
Manage training compliance across Functional Departments
Update trackers and handle project insights

Thermo Fisher Scientific Biotech: Biology + Technology Large https://www.thermofisher.com/

10001 Employees

HQ: Waltham

See more Thermo Fisher Scientific offers

Job description

Work Schedule

Environmental Conditions

Summarized Purpose:

In this exceptionally dynamic Project Specialist role, you will provide high-level end-to-end support services and oversight to increase efficiency and compliance across various Functional Departments. You will play a pivotal role in managing complex studies and programs, ensuring that project deliverables and targets are met to world-class standards.

Essential Functions:

Coordinate and lead all aspects of metrics in various systems to ensure flawless operations.
Coordinate and support assigned PSS staff as Lead, working closely with functional leads to determine efficient operational performance.
Introduce innovative ideas and smart new ways of working to help study teams maintain audit readiness.
Support the creation, implementation, and change management for departmental and cross-functional process improvements and enhancements.
Conduct risk assessment and analysis to avoid possible deviations and ensure strict compliance with established processes.
Provide comprehensive oversight and follow-up on study-level activities to minimize inconsistencies and ensure compliance with systems, organizational, and customer processes.
Coordinate, lead all aspects of, and follow up on systems and training for various Functional Departments, with the goal of achieving training compliance above 99%.
Join external meetings and teleconferences with clients as needed, and contribute to the development of presentations regarding performance indicators, measurements, updates, and possible obstacles.
Coordinate metrics in CRG's VV eTMF and Client eTMFs, including reconciliation of File Reviews.
Update and maintain trackers and data repositories, analyze results, and build action plans for the Project Lead/CTM.
Provide Clarity support by reviewing actual hours coded each month, identifying miscoding, and evaluating spend compared to budget.
Identify risks and communicate them in advance to Functional Leads and Client representatives.
Perform additional duties as necessary to support study teams and meet departmental and company objectives.

Qualifications:

Bachelor's degree or equivalent experience in a relevant field of study.
Previous experience (2+ years) that provides the knowledge, skills, and abilities to perform the job effectively.

Knowledge, Skills and Abilities:

Comprehensive understanding of PSC tasks, applicable manuals, eTMF, and File Review processes.
Awareness of audit/inspection processes and relevant rules and advisory materials.
Expert knowledge of applications (e.g., Excel), systems, or processes.
Strong organizational skills and attention to detail, with proven ability to balance multiple tasks efficiently.
Ability to analyze project-specific data/systems to ensure accuracy and efficiency.
Strong customer focus and ability to adjust workload priorities to meet changing project timelines.
Knowledge of ICH GCP, SOPs, and clinical trial life cycle.
Advanced English proficiency (verbal and written).
Proficient computer skills, including MS Office (Word, Excel, PowerPoint), and ability to master clinical trial database systems.
Strong collaboration and communication skills, with the ability to shift prioritization according to project needs.
Ability to work effectively in a team or independently.
Good negotiation skills.