Summary
Overview
Work history
Education
Skills
Languages
Soft Skills
Soft Skills
Timeline
Generic

Eylem Erdogan-Horoz

Berlin,Germany

Summary

Manager, Contracts/ Contract lead | 12+ Years of Experience in Clinical Trials
Experienced contract management professional with over 12 years in the clinical trials industry. Expertise in contract negotiations, stakeholder management, and clear, effective communication. Proven leadership skills in managing contract teams and collaborating effectively with cross-functional teams, including project managers, finance, procurement, and legal departments. Strong organizational abilities to manage multiple contracts and projects simultaneously while ensuring timely and successful execution.

Overview

14
14
years of professional experience
13
13
years of post-secondary education

Work history

Manager, Contracts Lead Contracts

ICON plc
Berlin, Germany
12.2023 - Current
  • Responsible for contract and budget negotiations with clinical trial sites worldwide , with experience in several countries across EU, APAC, and ROW (Rest of World) for Full Service Client (FSP).
  • Study Lead in Clinical Trials , managing teams responsible for contract and budget negotiations globally.
  • Serve as primary point of contact for contract-related matters for Turkey and DACH region, liaising with stakeholders to address any contract-related concerns. Provide guidance and support to FSP team on regional nuances and specific contract obligations, ensuring alignment with local laws and business practices. Train and support team members on region-specific contractual processes, templates, and best practices within FSP framework.
  • Participate in weekly study meetings with Sponsor , SSU (Site Start-Up) calls, and kick-off meetings.
  • Ensure assigned contract associates update Salesforce and sponsor systems in timely and consistent manner, providing concise and accurate information regarding status of contracts or change orders.
  • Lead Contract Associates assigned to project, ensuring Contract Associates are adequately trained on budget and negotiation instructions and are provided with all necessary information and templates related to projects.
  • Report status and potential issues/concerns to senior Client Contract Services management regarding contracts and change orders, along with proposed solutions.
  • Act as sponsor agreement liaison ; coordinate with sponsor contracting team regarding scope changes and required contract revisions.
  • Negotiate, draft, review/edit, and present for execution all legal documents and agreements on behalf of sponsor, including Confidentiality Agreements, Homecare Agreements, Service Agreements, Master Service Agreements, and related amendments.
  • Negotiate budgets/contracts with clinical trial sites .
  • Maintain both hard copy and electronic files of agreements.
  • Develop and implement strategies to continually enhance contract process , ensuring legal compliance while balancing business needs, core values, and market strategies.
  • Resolve issues regarding budget and payment terms .
  • Liaise with Sponsor and Clinical Team to ensure delivery of projects in compliance with guidelines provided by Sponsor.
  • Supervised project timelines for timely completion.
  • Fostered positive work environment with regular team-building activities.
  • Coordinated hiring, recruitment and training strategies to build successful administrative team.
  • Established clear budgets and cost controls strategies to meet objectives.
  • Analysed and resolved complex resource management issues for optimised scheduling.
  • Cultivated strong relationships with clients to secure repeat business.
  • Led performance reviews, identified areas for improvement.
  • Coordinated cross-departmental collaboration for improved workflow.
  • Liaised with suppliers to ensure timely deliveries
  • Managed team dynamics by implementing conflict resolution strategies.
  • Controlled resources by department or project and tracked use in CTMS, PSO.
  • Developed organisational policies for administrative oversight and internal controls.
  • Investigated issues affecting group operations, prepared reports and helped correct problems.
  • Handled negotiations with outside vendors and service agencies to meet group needs.
  • Led and managed administrative staff to maintain smooth daily operations.
  • Streamlined communication channels, enhanced internal information flow.
  • Streamlined processes to improve and optimise office operations.
  • Maintained smooth-running business operations by delegating priorities to staff abilities.

Manager, Contracts Manager / People Leader

ICON plc
Berlin, Germany
06.2022 - 11.2023
  • Lead an EMEA team of 14 Contract Associates and Study Leads in the FSP department.
  • Coordinate, lead, and facilitate the preparation and negotiation of contracts and budgets for various sponsors and countries, ensuring familiarity with local laws, regulations, and guidelines.
  • Focus on quality, efficiency, and cost containment in all contract and budget-related activities.
  • Mentor and lead a team of 14 Contract Associates and Clinical Trial Associate Leads (CTALs) , providing guidance and fostering the development of strong, capable teams.
  • Ensure compliance of direct reports with Client Contract Services SOPs, processes, guidelines, policies , and any other related items within the Client Contract Services group.
  • Review all documents through quality checks before sending them to the sponsor or sites, ensuring finalization of negotiations and signatures.
  • Support the team in resolving challenging situations with sites or sponsors.
  • Continually assess opportunities for process improvement to enhance the efficiency and effectiveness of the contract management process.
  • Monitor and manage staff workload , ensuring tasks are balanced and completed in a timely manner.
  • Ensure direct reports update Salesforce in a timely and consistent manner , providing concise and accurate information on the status of contracts or change orders.
  • Understand and challenge supporting information provided by the project team related to budget changes (timeline, specifications, tasks, hours, etc.), ensuring the budget changes are reasonable and justified.
  • Support the team in managing and prioritizing workload in relation to business needs, timelines, and client submissions, with consistent accuracy and speed.
  • Coach and mentor new employees on country-specific processes for Turkey and the DACH region within the FSP framework.

Contract Associate 3

ICON plc, formerly PRA Health Science
Berlin, Germany
10.2021 - 06.2022
  • Serve as the primary contact negotiator for all study-related contract activities for various clients , ensuring alignment with business objectives.
  • Prepare, negotiate, analyze, escalate, and finalize all required site agreements and budgets in a timely and efficient manner.
  • Utilize legal and budget parameters as fallback options to expedite negotiations and facilitate smoother contract closures.
  • Ensure regular communication and escalate issues to expedite the planning, execution, issue resolution, and management of Site/Investigator agreements and other essential documents.
  • Responsible for contract and budget negotiations with clinical trial sites worldwide , with extensive experience in multiple countries across the EU, APAC, and ROW (Rest of the World).
  • Serve as Study Lead in Clinical Trials , managing teams responsible for global contract and budget negotiations.
  • Maintain active and frequent communication with sponsors, internal/external partners, investigators, and internal departments throughout the entire contract lifecycle.
  • Review and negotiate terms and conditions for various types of incoming and outgoing contracts and budgets , ensuring compliance with internal policies and ICH-GCP regulations.
  • Prepare contract amendments, notes to files, and other contract-related documentation as needed.
  • Develop and maintain status trackers , and prepare start-up and close-out documentation for clinical studies.
  • Act as the primary point of contact for contract-related matters for Turkey and the DACH region , liaising with stakeholders to address any contract-related concerns. Provide guidance and support to the FSP team on regional nuances and specific contract obligations, ensuring alignment with local laws and business practices. Train and support team members on region-specific contractual processes, templates, and best practices within FSP department.

Contract Associate 2

ICON plc, formerly PRA Health Sciences
Berlin, Germany
11.2020 - 09.2021
  • Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for various sponsor and/or investigator-initiated studies, either through direct negotiation with clinical trial sites or by overseeing a Clinical Research Organization responsible for contract negotiations. Ensure delivery on established targets and performance metrics.
  • Collaborate with global teams to review and analyze contractual terms and conditions, assessing legal and budget risks in conjunction with support functions.
  • Partner with Healthcare Compliance, Risk Management, Privacy, and other stakeholders to obtain guidance and drive resolution of contract-related issues.
  • Provide support for negotiations of confidentiality agreements, informed consent forms , and other ancillary contract documents as required.
  • Manage the contract amendment lifecycle , ensuring timely updates and revisions.
  • Work with global teams as needed to review and analyze contractual terms, assess risks related to budget and legal provisions, and escalate issues as appropriate for resolution.
  • Proactively improve processes and establish refinements to reduce cycle time, create savings, and enhance efficiency in the initiation of clinical trial sites.
  • Adhere to SOPs, ethical standards, and departmental compliance as determined by GCDO management, as well as operating companies, corporate guidelines, HCC, and QA standards. Ensure familiarity with departmental and corporate processes, including relevant policies and procedures.

Contract Associate 1

ICON plc former PRA Health Sciences
Berlin , Germany
09.2019 - 10.2020
  • Established and successfully negotiated clinical trial agreements with investigative sites, ensuring smooth contract execution.
  • Work cross-functionally with Clinical Operations and Project Management to support timely site start-up for clinical trials, including the accurate forecasting of contract execution timelines.
  • Collaborate with the Functional Manager , partnering with other compliance departments to ensure adherence to country-specific laws and regulations, minimizing risk in clinical trials.
  • Communicate and explain legal and budgetary issues to internal and external parties in accordance with department guidelines.
  • Review and evaluate client-requested contract changes , and escalate deviations based on department guidelines as appropriate.
  • Create and maintain files for each contract , ensuring proper documentation and organization.
  • Participate in client meetings to expedite the contract signing process, as directed.

Clinical Operational Assistant Functional Service

Parexel International GmbH
Berlin, Germany
05.2016 - 08.2019
  • Support in the planning, coordination, and execution of clinical trials in accordance with GCP (Good Clinical Practice) and internal SOPs (Standard Operating Procedures).
  • Assist in the preparation of documents for submission to ethics committees and regulatory authorities.
  • Set up, maintain, organize, and archive the Trial Master File , including assisting with the quality control of documents.
  • General administration of internal documentation , including the creation and maintenance of study-related tracking tools.
  • Provide general assistance , including executive support, organizing meetings and business trips.
  • Prepare presentations and meeting minutes as needed.

Administrative assistant Early Product Development

Parexel International GmbH
Berlin, Germany
11.2011 - 05.2016
  • Support the EPD Project Leader (PL) in setting up and executing PAREXEL projects (clinical trials), adhering to standard operating procedures, templates, tools, and systems.
  • Assist with project initiation and planning , execution, monitoring, and project closure.
  • Conduct data analysis of study status (current vs. actual), ensuring overall team compliance.
  • Assist in creating the study timeline , ensuring milestones are met on schedule.
  • Support and communicate with the project team in developing solutions for “what-if” scenarios to ensure proactive decision-making and resolutions.
  • Plan and implement key documents, plans, and reports for the project.
  • Responsible for quality control of study documents , ensuring they meet project-specific requirements.
  • Organize project-specific training for team members under the direction of the PL.
  • Assist the PL in preparing submission documents in both German and English for local regulatory authorities.
  • Input data and create or duplicate regulatory and planning documents as needed.
  • Handle correspondence in English, ensuring clear and professional communication.

Education

Law

Freie Universität
Berlin
04.2001 - 10.2013

Skills

  • Negotiation Skills – Expertise in negotiating terms in clinical contracts with sponsors, vendors, and service providers, while balancing legal, regulatory, and business requirements to ensure optimal outcomes
  • Stakeholder Management – Ability to liaise with internal teams (legal, finance, procurement, etc) and external stakeholders (clients, vendors) to ensure alignment and smooth contract execution
  • Clear Communication – Ability to convey complex legal concepts in understandable way to non-legal stakeholders, ensuring clarity in contract terms and conditions
  • Presentation Skills – Ability to present contract proposals, updates, and complex issues to senior management and clients
  • Team Leadership – Experience in leading and mentoring contract teams, ensuring contract tams follow processes and deliver on targets
  • Cross-functional Collaboration – Ability to work closely with project managers, finance, procurement, and legal teams to align on contract terms and objectives
  • Project Management – Strong organizational skills for managing multiple contracts and projects simultaneously, ensuring deadlines are met

Languages

German
Native
Turkish
Native
English
Fluent

Soft Skills

  • MS Office
  • SAP

Soft Skills

  • Communication – Clear and concise communication, both verbal and written, to explain complex legal concepts and ensure stakeholders are aligned on contract terms and expectations.
  • Leadership and Mentoring – Proven ability to lead, mentor, and develop contract teams, providing guidance and fostering a collaborative work environment to ensure successful contract execution.
  • Problem-Solving – Strong analytical thinking and the ability to identify issues, assess risks, and provide effective solutions in contract negotiations and management.
  • Attention to Detail – High level of accuracy in reviewing contracts, ensuring compliance with legal requirements, and identifying potential risks or discrepancies.
  • Time Management – Ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast-paced, high-pressure environment.

Timeline

Manager, Contracts Lead Contracts

ICON plc
12.2023 - Current

Manager, Contracts Manager / People Leader

ICON plc
06.2022 - 11.2023

Contract Associate 3

ICON plc, formerly PRA Health Science
10.2021 - 06.2022

Contract Associate 2

ICON plc, formerly PRA Health Sciences
11.2020 - 09.2021

Contract Associate 1

ICON plc former PRA Health Sciences
09.2019 - 10.2020

Clinical Operational Assistant Functional Service

Parexel International GmbH
05.2016 - 08.2019

Administrative assistant Early Product Development

Parexel International GmbH
11.2011 - 05.2016

Law

Freie Universität
04.2001 - 10.2013

Similar Profiles

Create profile
Eylem Erdogan-Horoz