TMF Partnership Lead - Poland - FSP

If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at TMF Partnership Lead, home-based and sponsor dedicated, in Poland.

We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.

As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.

You will work from your home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.

The most significant aspect of this position is

• Contributes to the development and assists with the implementation of the TMF specifications, such as process and system changes.
• Leads the set-up of the TMF Study Specific Document List (SSDL) and monitors completeness and quality of TMF content for all assigned clinical trials until study close out.
• Ensures documentation flow is within projected timelines and determines course of actions to prevent and remediate timeline delays.
• Ensures consistent use of standardized processes and technologies across clinical trials and programs.
• Serves as point of contact for internal and external audits of study TMF-related queries.
• Actively identifies continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.
• Provides support and guidance to the study teams to drive performance against metric targets.
• Applies lessons learned to continuous improvement of documentation management practices across study teams.
• Provides education, feedback and support to study teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
• Ensures that the program documentation supports the regulatory package requirements.
• Clinical Study Start-up/Study Conduct/Study Close-out
  • Determines and reviews study specific TMF specifications to ensure quality and standardization are established per program and kept up to date as program/protocols progress.
    • Assesses impact of potential changes to TMF specifications prior to implementation and collaborates with PM or equivalent if modifications are necessary.
    • Maintains Study Specific Document Lists (SSDLs) at the study, country and site levels by collaborating with all relevant Functional Lines (e.g., Data Management, Clinical, Regulatory, etc.) to ensure placeholders are correctly and accurately in place for the study and all versions and instances are filed in a timely manner.
    • May support document processing per document QC checks and other reference documents.
  • Supports the preparation of appropriate audit and inspection responses.
  • Supports study team in the effective management of TMF when working external vendors.
  • Analyzes error trends in documentation and provides feedback to the TMF Study Owner Leads and TMF Operations to enable continuous improvement.
  • Supports study team to ensure document quality requirements are agreed to and met, according to Completeness, Timeliness and Quality metrics.
  • Enforces ownership and accountability across study teams regarding readiness of TMF documents.
  • Supports study team in addressing/reporting regulatory queries pertaining to document management.
  • Supports study team in resolving TMF content issues.
  • Ensures complete TMF is in place at time of study close/submission.
  • Facilitates communication and interaction among study team members from the set up until the closing (e.g., TMF)
    

From you we expect

• Bachelor degree

• Minimum 5 years TMF experience management.

• Experience/knowledge of ICH/GCP documentation requirements.
• Clinical documentation management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
• Experience with the following application types:
  • Electronic documentation management systems
  • Web based data management systems, as required
  • Database utilization
• Experience supporting the documentation components of regulatory submissions and inspections preferred.
• History of achievement in a customer service role with demonstration of meeting customer needs and concerns.
• Strong background in provision of high levels of customer service evidenced by positive feedback from customers.
• History of achievement in building strong customer relationships.
• Experience of working across international boundaries and cultures.
• History of achievement in negotiation and conflict resolution, and working in high-stress situations.

• Extensive knowledge of clinical development process including in depth knowledge and understanding of the principles of GCP;
• Extensive knowledge of TMF and document requirements;
• Working knowledge of electronic document management systems.
• Ability to work independently; Ability to organize tasks, time and priorities of self and others; Ability to multi-task.
• Strong verbal and written communication skills, combined with outstanding listening skills;
• Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally;
• Ability to use a variety of communication tools and techniques to explain difficult issues and works to establish consensus.
• Ability to manage studies and processes to agreed quality and timelines
• Attention to detail evident in a disciplined approach to document maintenance and management
• Knowledge of the clinical development process, understand concepts of Phase I-IV and principles of study design
• Understanding of scientific/clinical principles, and ability to work across different therapeutic areas
• Extensive knowledge/understanding of technologies to support document collection and archiving; awareness of CFR 21 part 11
• Ability to make moderately complex decisions that require choosing between multiple options and have the potential to impact the delivery of the program/project and resource on the program/project.
• Ability to work in ambiguous situations within the team to identify and resolve complex problems.

Base Pay Range for Poland: 220,000 - 235,000 PLN gross annual​

Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.

In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and total rewards incentives.

Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles.

For an immediate interview, please contact marta.kuniewicz@parexel.com