Clinical Trial Coordinator null

Your role

Under the oversight of the line manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

The role is critical to meeting planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at the local level closely with COM, CRM and CRA. The person collaborates with finance/budgeting representatives to manage CTRAs and payments.

Responsibilities include but are not limited to

• Trial and site administration:
  • Track (e.g. essential documents) and report (e.g. Safety Reports)
  • Ensure collation and distribution of study tools and documents
  • Update clinical trial databases (CTMS) and trackers
  • Clinical supply & non-clinical supply management, in collaboration with other country roles
  • Manage Labeling requirements and coordinate/sign translation change requests, in collaboration with other country roles (if applicable)
• Document management:
  • Prepare documents and correspondence
  • Collate, distribute/ship, and archive clinical documents, e.g. eTMF
  • Assist with eTMF reconciliation
  • Execute eTMF Quality Control Plan
  • Update manuals/documents (e.g., patient diaries, instructions)
  • Document proper destruction of clinical supplies
  • Prepare Investigator trial file binders
  • Obtain translations of documents
• Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
  • In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
  • Obtain, track and update study insurance certificates
  • Support preparation of submission package for IRB/ERC and support regulatory agencies' submissions
  • Publish study results for GCTO and RA where required per local legislation
• Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:
  • Develop, control, update and close-out country and site budgets (including Split site budget)
  • Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
  • Track and report contract negotiations
  • Update and maintain contract templates (in cooperation with the Legal Department)
  • Calculate and execute payments (to investigators, vendors, grants)
  • Ensure adherence to financial and compliance procedures
  • Monitor and track adherence and disclosures
  • Maintain tracking tools
  • Obtain and process FCPA documentation in a timely manner
• Meeting Planning:
  • Organize meetings (create & track study memos/letters/protocols)
  • Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

About you

Skills

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Hands-on knowledge of Good Documentation Practices
• Good IT skills (Use of MS Office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills are required
• ICH-GCP Knowledge appropriate to the role
• Excellent negotiation skills for CTCs in the finance area
• Effective time management, organizational and interpersonal skills, conflict management
• Effective communication with external customers (e.g. sites and investigators)
• High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships
• Demonstrates commitment to Customer focus, both internally and externally
• Able to work independently
• Proactive attitude to solving problems / proposing solutions
• Positive mindset, growth mindset

Qualification & experience

• Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree

What they look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of time. Their team is constantly evolving, so if you are among the intellectually curious, join MSD and start making your impact today.

Benefits

Because their people are their greatest asset, MSD empowers and supports them in their professional and personal lives by providing benefits including:

• Competitive base pay, short- and long-term incentives to support your life journey
• Vacation, holidays, & year-end shutdown
• Global recognition program
• Health, life, disability, & business travel insurance
• Global flexible work arrangements
• Fitness, health and meditation resources
• Coaching and mental health therapy sessions
• On-site cafeterias and play and relaxation areas

To learn more about diversity and culture at MSD, watch this video:

Training & development

MSD emphasizes professional growth and collaboration, fostering a culture of inclusion and innovation. They support employees through resources and opportunities that enhance individual skills and encourage teamwork. By celebrating diversity and promoting a respectful, empowering environment, MSD aims to inspire employees and drive scientific excellence.

Career progression

Sherif Chalifa, a Business Analyst for Quality Systems at MSD, highlights the company's strong emphasis on career progression through a supportive and inclusive work environment. He experienced a seamless onboarding process and valued the team’s commitment to collaboration and personal growth. MSD's focus on employee development, continuous feedback, and a culture of teamwork creates a promising foundation for career advancement and personal fulfilment. Read more about his story here.

Sources

The following sources were used in researching this page:

• jobs.msd.com/gb/en/compensation-benefits
• msd.com/company-overview/culture-and-values/
• jobs.msd.com/gb/en/blogarticle/embracing-growth-collaboration
• youtube.com