Associate Clinical Trial Regulatory Manager

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Associate Clinical Trial Regulatory Manager, Madrid

Client: Clinipace

Location: Madrid, Spain

Job Category: Other

EU work permit required: Yes

Job Reference: 397068826719551488032460

Job Views: 2

Posted: 11.03.2025

Expiry Date: 25.04.2025

Job Description:

Job Title: Associate Clinical Trial Regulatory Manager (ROW)

Job Location: Madrid, Spain (Home-based, any location in Spain considered)

Job Overview: The Associate Clinical Trials Regulatory Manager (CTRM) will oversee the maintenance phase of a clinical study following initial site activation through study closure. The Associate Clinical Trial Regulatory Manager directly supports the study Project Manager by collaborating with Clinical Trial Manager (CTM), Clinical Trial Associate (CTA), and Country Specialists.

Job Duties and Responsibilities:

1. Prepare timelines and oversee the execution of the Clinical Trial Application Amendments (CTAA) and clearly communicate with the internal and Sponsor project teams.
2. May support initial start-up activities (prior Site Initiation Visits) for a limited number of sites.
3. Responsible for tracking relevant timelines and activities; and reporting on the progress to the study team and the Sponsor per agreed frequency.
4. Manage Country Specialists (including contracted individuals) appointed to the project ensuring their project-related training is completed prior to performing any project activities as detailed by relevant SOPs.
5. Prepare the CORE CTAA package; including the review of the relevant documents (protocol, IB, IMPD, and any patient-facing documents as applicable) and obtain acceptance from the project manager and approval from the client for the document package.
6. Review and approval of CA/EC Country amendment submission dossier; and may perform Country Amendment submissions to CA/EC including queries management.
7. May draft cover letters, support review of ICFs, review translations, provide summarized translations for GNA/deficiencies, and communicate with the CEC and/or CA in local language, as necessary.
8. Inform project team about amendment approvals for immediate implementation.
9. Accountable for Annual Progress Report submission, End of Trial notification, Clinical Study Report submission.
10. May be responsible for translation of requested SSU documents and communication link with translation vendor.
11. Capable to independently operate in electronic databases and systems such as Trial Master Trials, CTMS, and time recording following relevant training.
12. May act as a regional Start-Up Lead or Country Expert depending on experience and current Clinipace needs.
13. Capable to provide regional or local country procedural and legal advice/guidance to internal and Sponsor project teams.
14. Demonstrates flexibility, patience, strong attention to detail and excellent time management.

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

1. Education: Bachelor’s graduate with a healthcare or life science degree or equivalent experience.
2. Experience: Minimum of 4 years of experience in the Clinical Research industry, country start-up specialist experience in a Clinical Research Organization (CRO) setting preferred.
3. Experience with clinical study startup with hands-on experience of regulatory and site activation preferred.
4. Working knowledge of regulations; has expertise to work in accordance with local guidelines (provided by local experts in each country).
5. Experience in coordination activities at regional/international level.
6. Skills/Competencies: Strong written and verbal communication skills; speaks clearly, listens, and reacts calmly; and understandably communicates with sponsors and internal team members who may not be familiar with regulatory and start-up requirements and processes.
7. Able to establish effective relationships with sponsors and internal team members.
8. Time management: able to work within tight and detailed timelines, can prioritize work based on the pre-defined milestones.
9. Ability to problem solve and work independently and pro-actively.
10. Able to exercise judgment within defined procedures and practices and to determine appropriate action independently; able to clearly convey any issues and proposed potential solution.
11. Strong computer skills, including Microsoft Office.
12. Comprehensive knowledge of GCP/ICH guidelines.
13. Exceptional attention to detail.
14. Open to change in fast-moving environment.
15. Planning/Organizing - Prioritizes and plans work activities, uses time efficiently, and develops realistic action plans. Demonstrates flexibility and willingness to learn new skills relevant to the position.
16. Capabilities: Windows; proficient in MS Word, Excel, Power Point, One Note, Teams.
17. Experienced in utilizing regulatory intelligence databases.
18. Excellent organizational skills.
19. Excellent personal interaction skills.
20. Team player with some leadership experience.
21. Exceptional English written and oral communication skills; proficiency in another language is an advantage.

The company will not accept unsolicited resumes from third party vendors.