Senior Clinical Trial Documentation Specialist

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.

We see human behind every number.

Senior Clinical Trial Documentation Specialist

Location: Warsaw (Poland, office based/hybrid)

Summary of Job Specification

Senior Clinical Trial Documentation Specialist is responsible for realization of end-to-end clinical documentation activities related with different aspects of document processing and document management tools and systems development according to applicable regulations and standards. The Senior Specialist’s tasks depend on the process/project/role assigned. He/She assumes role of superuser/admin and is responsible for knowledge management and continuous improvement inside relevant applications within the department.

Detailed Job Duties and Responsibilities

• Acts as the TMF Lead, informs Line Manager about any problems/issues arising during the cooperation with functional areas

• Communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF

• Builds relationships with key customers and a network of business contacts in order to seek cooperation
  opportunities

• Cooperates directly with customers to understand customer’s needs and deliver data solutions compliant
  with customer’s requirements

• Verifies the availability of expected documentation in TMF

• Leads Documentation Specialists assigned to the study

• Analyses trends, gaps, and metrics to ensure proper escalation

• Performs documentation management activities for assigned TMF according to applicable regulations, procedures and TMF Plans

• Processes clinical trial documents using manual and automated methods - in relevant computerized systems (e.g., eTMF) to ensure the overall documents quality and the TMF completeness

• Oversees quality control process, performs 2nd level quality check of clinical trial documents

• Identifies, prioritizes, and monitors quality issues to maintain compliance with resolution

• Ensures that all clinical trial documents are in steady state according to key metrics

• Monitors the TMF completeness to achieve Inspection Readiness at each milestone

• Liaises with KCR functional area project team members and document owners in the scope of assigned activities and projects for TMF related requirements

• Shares knowledge and expertise with other departments and customers, actively promotes clinical trial documentation quality, integrity rules and awareness

• Participates in internal initiatives and additional activities (as assigned by Line Manager)

• Performs other duties if assigned by Line Manager

• Acts as Subject Matter Expert in eTMF system

• Acts as a mentor Peer Buddy for less experienced staff

• Performs computerized systems configuration and validations and prepares associated documentation

• Accountable and responsible for system administration and provision of end user support and training

• Develops business opportunities in line with the strategy defined for the Documentation Service

• Prepares budgets based on RfP assumptions

• Handles data requests and reports

• Performs data processing activities including data collection, data transfer, modelling, analysis and visualization

• Performs cross-checking between countries/sites (levels) for particular sections with regards to sub-sections / classifications, document titles

Requirements:

• University degree in a life-science/healthcare/pharmaceutical related fields

• Minimum of 3 years of clinical research experience with eTMF

• Advanced verbal and written English language skills

• Postgraduate certification in Clinical Trials is an additional value

• Good understanding of ICH GCP/EMA/FDA and local regulations and standards applicable for DS area

• Experience with internal processes and ability to act as superuser or admin to find solutions to problem

• Organizational, workload prioritization and time management skills

• Good communication and interpersonal skills

• Able to work under time pressure in a changing environment with flexibility

• Analytical and problem-solving capabilities and skills

• Customer focus with sense of urgency

• Good IT skills (Outlook, Excel, browsing and communication tools, e.g., Teams, WebEx)

• Occasional travel might be required

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs. To show that you are appreciated in our team, while working at KCR you will be provided with: 

• 1 additional day off for your birthday;

• Private medical healthcare;

• Sport card;

• Loyalty Bonus Program (anniversary awards or additional paid time off);

• Additional days off at the end of year (up to 4 days);

• Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry;

• Possibility of getting involved in IT activities in regions: US, Western/Central/Eastern Europe;

• Onboarding process to enable you fast takeover of duties;

• Peer Buddy Mentor who will introduce you to the organization;

• Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed;

• Empowering workspace, offering opportunities to share ideas and influence company services development worldwide.

Our Privacy Policy

Your data will be processed in accordance with KCR Group Privacy Policy. For more details click here: https://www.kcrcro.com/privacy-policy/#privacy.

Providing your personal data is voluntary, however, if you do not provide us with the necessary information, we will not be legally allowed to get in touch with you and consider your application. By sending application documents containing your personal data to a wider extent than required by provisions of the applicable laws, you are granting consent for the data to be processed for the purposes of the ongoing recruitment.

You may also agree to enable other employers within KCR Group to communicate with you about potential job opportunities that match your area of expertise and interests.

If you would like your candidacy to also be considered for future recruitments, please select an additional consent or add the following statement to your application documents: “I agree to the processing of my personal data for any future recruitments conducted by KCR and/or KCR affiliates for a period of up to 3 years”. Such consent may be placed in your CV or electronic correspondence addressed to your potential employer.

You may withdraw any consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.

Your personal data will be shared with KCR and/or KCR affiliate that you are pursuing, and that company will be considered a separate data controller of your personal data. A full list of KCR affiliates is available at: https://www.kcrcro.com/privacy-policy/#kcr-entities.

You can contact KCR Group Data Protection Officer at gdpr@kcrcro.com any time with any questions or concerns regarding how your personal data is processed.

KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all.

We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sectors. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.

If you require reasonable accommodations to participate in the application process, please let us know by email: eeo@kcrcro.com. We are committed to ensuring equal opportunity for all applicants and will work to provide reasonable accommodations to support your needs.