Job Opportunities in Poland
October 16, 2024
Thermo Fisher Scientific
Warszawa
OTHER
Project Support Specialist - Client-dedicated
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, 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 make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond 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 outcomes that people and communities depend on – now and in the future.
Due to the constant expansion of our global centralized functions in Sofia we’re opening opportunities for professionals within the Project Support Services group in the role of Project Support Specialist.
In this role you would provide high-level end-to-end support services and oversight to increase efficiency and compliance in different Functional Departments primarily focusing on big and complex studies and programs. The Project Support Specialist has to ensure project deliverables and targets are met according to the highest quality standards. If a successful candidate, you will also be responsible for managing the metrics in various systems. You will help study teams to maintain audit readiness by bringing forward innovative ideas and smart new ways of working, support creation, implementation and change management for departmental and cross-functional process improvements/enhancements initiatives. You will also support with risk assessment and analysis to avoid possible deviations and noncompliance with established processes.
Summarized Purpose:
Required Education/Experience:
Knowledge, Skills and Abilities Required:
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
What we offer:
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #Start Your Story with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, 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 make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond 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 outcomes that people and communities depend on – now and in the future.
Due to the constant expansion of our global centralized functions in Sofia we’re opening opportunities for professionals within the Project Support Services group in the role of Project Support Specialist.
In this role you would provide high-level end-to-end support services and oversight to increase efficiency and compliance in different Functional Departments primarily focusing on big and complex studies and programs. The Project Support Specialist has to ensure project deliverables and targets are met according to the highest quality standards. If a successful candidate, you will also be responsible for managing the metrics in various systems. You will help study teams to maintain audit readiness by bringing forward innovative ideas and smart new ways of working, support creation, implementation and change management for departmental and cross-functional process improvements/enhancements initiatives. You will also support with risk assessment and analysis to avoid possible deviations and noncompliance with established processes.
Summarized Purpose:
- End-to-end oversight and follow up on study level activities aiming to minimize any inconsistencies in terms of compliance with systems, organizational/customers processes, and procedures accurately applied at all levels.
- Reconciliation, oversight and follow up on systems and trainings for various Functional Departments. Direct communication with Functional Leads to follow up and increase training compliance >99% on study level.
- Attends (if required) external meetings & teleconferences with the client. Support with preparation of presentations including information about Key Performance Indicators (KPI), metrics, status and possible challenges with systems.
- Oversight of metrics in PPD's VV e TMF and Client e TMFs; reconciliation of File Reviews.
- Updating and maintaining trackers and data repositories as required. Assessment/analysis of results and potential action plan suggested to Project Lead/CTM.
- Provide Clarity support with review of actual hours coded each month to identify miscoding; evaluate spend compared to budget.
- Identification of risks and communication in advance to Functional Leads.
- Additional duties may be assigned to provide support to the study teams based on business needs and/or to meet overall objectives of the department/company.
Required Education/Experience:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job in Clinical Research Organization and/or centralized/global end-to-end project support role (comparable to 5+ years’).
Knowledge, Skills and Abilities Required:
- Very good understanding of CTC-C tasks, applicable CTC-Cs' and other manuals, e TMF and File Review processes, client-specific manuals, procedures and requirements.
- Audit/inspection process awareness with relevant rules and guidance documents.
- Expert knowledge of an application (e.g. Excel), system or process.
- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently 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 several MS Office (Word, Excel, Power Point) and ability to obtain knowledge and master all clinical trial database systems.
- Strong collaborators, very good communication skills, capable to shift prioritization according to project needs and timelines.
- Ability to work in a team or independently as required.
- Good negotiation skills.
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
What we offer:
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #Start Your Story with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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