Sr. Clinical Trial Manager, Poland

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At Exact Sciences were helpingchange how the world prevents detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career an inclusive culture and robust benefits to support your life while youre working to help others.

Position Overview

The Sr. Clinical Trial Manager (CTM) Poland will be part of the Clinical Affairs Team which is responsible for planning executing managing and closing projects associated with the company clinical study plans. The Sr. Clinical Trial Manager Poland manages executes and reports on clinical study operations and provides support to members of the multidisciplinary project team internally and externally. The Sr. Clinical Trial Manager Poland may work in conjunction with and/or with direction from a Clinical Study Manager. The CTM works collaboratively and cross-functionally in an exciting fast paced environment to oversee the day-to-day operations of assigned clinical studies and ensure the successful execution of the companys clinical research plans.

Essential Duties

Include but are not limited to the following:

• Act as a customer advocate throughout the project lifecycle.
• Understand and support global project goals including site recruitment patient recruitment marketing and PR as appropriate.
• Implement approved clinical study protocols. Develop study-specific consent forms and other trial related materials (e.g. Study Monitoring Plan Patient Guide Project Plan etc.) as required.
• Coordinate with applicable cross-functional teams (e.g. R & D Operations Exact Sciences Laboratories) to identify goals and scope of clinical study projects; Manage and execute the overall project scope and timelines.
• Initiate and train sites to the study protocol; ensure proper site adherence to clinical research regulations.
• Manage resources and timelines associated with all study start-up and implementation activities including CRO/investigator agreements central IRBs and contractual agreements.
• Support the management and oversight of CROs and other clinical study related vendors as applicable.
• Plans for and manages all materials to support the appropriate execution of the clinical projects including but not limited to distribution of documents forms supplies equipment and investigational device.
• Ensure maintenance of document standardization using model documents templates and appropriate peer review.
• Ensure the appropriate development of all documents by CROs including but not limited to study documents including informed consent forms case report forms and instructions site selection materials investigator updates and other project-specific documents required for the conduct of assigned studies.
• Assume primary accountability for assigned clinical research projects and ensure compliance with applicable regulations guidelines and corporate policies for study activities.
• Ensure the development and maintenance of project-specific tracking systems to enable proper study management and monitoring activities as required.
• Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections as needed.
• Develop and maintain detailed timelines and resource projections for all programs.
• Prepare and distribute appropriate communications required to properly manage and document activities on the studies.
• Facilitate the completion of database development statistical analysis and clinical study report writing.
• Manage relationships with consultants to provide adequate support and services for data collection and analysis.
• Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
• Attend off-site meetings and conferences as needed.
• Uphold company mission and values through accountability innovation integrity quality and teamwork.
• Support and comply with the companys Quality Management System policies and procedures.
• Regular and reliable attendance.
• Demonstrates problem-solving and interpersonal skills.
• Must have a can-do attitude and a strong desire to take ownership of many different projects.
• Strong desire to work in a fast-paced environment.
• Ability to work independently and manage multiple timelines while maintaining the team focus.
• Ability to exercise judgment and determine appropriate action for a wide range of issues of varying complexity.
• Ability to manage multiple deadlines.
• Ability to frequently and accurately communicate with employees customers and vendors in person via the telephone or by email.
• Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
• Ability to sit and/or stand for an extended period.
• Ability to lift and move up to 40 pounds on an occasional basis.
• Ability and willingness to travel (by land and air) on occasion.

Minimum Qualifications

• Bachelors degree in the life sciences or field as outlined in the essential duties.
• Minimum 5 years experience in clinical research with at least one year of clinical research experience with sponsor/CRO. Additional experience as a study coordinator or clinical research associate preferred.
• Clinical monitoring experience including data review/query resolution protocol deviation tracking/trending clinical site payment set-up/review and clinical sample management.
• Experience writing reviewing and editing protocols.
• Sample management system set-up experience. Demonstrates knowledge of Good Clinical Practices and all applicable US regulations governing clinical research as well as working knowledge of the FDA submission process including IDE PMA and 510(k).
• Excellent organization and communication skills including experience dealing with decision-makers such as physicians IRB members and FDA staff.
• Fluency in the English language (C1 or above per CEFR framework).
• Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Experience providing oversight to external vendors (e.g. CRO central labs call centers DCT providers).

Preferred Qualifications

• 1 year of clinical research experience with a sponsor company or CRO.
• International study experience IVDR and GDPR implementation.
• Working knowledge of the FDA submission process including IDE PMA and 510(k).
• Experience as a study coordinator or clinical research associate.
• Sample management system experience.
• Experience participating in the qualification and management of external vendors (e.g. CRO Call Center Central labs etc.).
• Experience contributing to project operational teams through the start-up study conduct and data management.
• Oral and written proficiency in European languages (French German Italian Polish Spanish) and/or Japanese.

Our success relies on the experiences and perspectives of a diverse team and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation please contact us here.

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