Experience Inc. Jobs

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 – To enable 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.

Alongside clinical research through our PPD® clinical research portfolio, our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.

Do you have a data entry/quality compliance background?

Interested in the dynamic clinical research industry?

We are currently looking to recruit a Data Compliance Specialist for our clinical site in Warsaw.

Summarized Purpose:

Provides compliance support to the clinical trial process by ensuring all study documentation and source data is captured accurately in eCRF, up to date and first time right. Performs quality reviews and answers any eCRF queries in a timely manner. Reviews accuracy of the Investigator Site Files (ISF) as well as performs quality compliance checks and answering any CRF queries in a timely manner.

Key responsibilities:

• Act as the primary point of contact for sponsors representative.

• Maintains ISF and study trackers as delegated and ensures that ICFs are correctly completed.

• Completes data capturing activities on one or more studies across multiple sites and regions.

• Ensures accurate and timely entry of all data in the eCRF from the source notes and tracks the flow of the eCRFs and queries.

• Verifies protocol visit windows are correct according to the protocol requirements and reports deviations.

• Assists monitors and sponsor representatives with query resolutions after monitoring visits.

• Interprets and adheres to company SOP and COP and assists with input during the review process.

• Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.

• Assists with drafting compliance reports.

• Assists with archiving procedures as needed.

• Liaises frequently with monitors and client representatives. Performs preparation of monitoring visit duties and clarifies any expectations relating to CRFs. Cooperating with vendors

• Supports audit preparation and ensures audit readiness.

• Identifies and escalates common data errors and trends and may assist with CAPA and problem solving methods.

Education and 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 (comparable to 2+ years).

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.

Knowledge, Skills and Abilities:

• Professional knowledge of theory and techniques in the data and compliance field

• Ability to multi-task and have oversight over numerous studies with a variety of therapeutic areas and size simultaneously

• Knowledge of all types of audit preparations and ability to provide oversight during audits

• Above average industry knowledge of quality compliance and GCP regulations

• Excellent interpersonal, leadership and consultation skills

• Good working knowledge of Business English, fluency in Polish language

• Good MS Office and computer skills

• Basic medical terminology knowledge

• Solid time management skills

• Strong attention to detail

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.