Clinical Trial Coordinator

Curious and Ambitious Clinical Trial Coordinator (CTC) for our company in Sweden

About the Position
As a cornerstone of the Clinical Trial process, the CTC plays a vital role in driving groundbreaking research and making a positive impact on patients’ lives. We are seeking a passionate and driven individual to join our dynamic team. The CTC is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. In this critical role, the CTC ensures deliverables are met for given projects according to both our companys standard as well as local regulations. Under the oversight of the COM Lead the person we are looking for will be responsible for but not limited to:

Trial and site administration

• Track and collect (e.g. essential documents) and report (e.g. Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases and trackers
• Clinical supply & non-clinical supply management, in collaboration with other country roles
• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles

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

Budgeting, agreement and payments through close collaboration with finance/budgeting representatives

• Develop, control, update and close-out country and site budgets
• Calculate and execute payments (to investigators, vendors, grants)
• Ensure adherence to financial and compliance procedures and obtain and process FCPA documentation in a timely manner
• Maintain tracking tools
• Support with pharmacy agreements

Meeting planning

• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

You will also contribute as subject matter expert (SME), providing trainings and mentoring other CTCs

About you

We are looking for a colleague who embodies a curiosity-driven mindset and thrives on solving complex problems.

Furthermore, our ideal candidate should:

• Have excellent verbal and written language skills in both Swedish and in English and excellent communication skills
• Ability to work with multiple deliverables, protocols and a wide range of people simultaneously
• Have sense of accountability / urgency with ability to set priorities
• Have a proactive attitude to solving problems / proposing solutions
• Have positive mindset, growth mindset, capable of working independently, and being self-driven
• Have at least one year of experience in clinical research or combined experience in clinical research or relevant healthcare experience. For Senior CTC role at least 3 years of experience
• Hold a bachelor’s degree within the fields of Life Science or other relevant fields
• Experience with various tools (for example Veeva Vault and CTMS

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
  

Job Posting End Date:07/02/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R302406