Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 31 hours ago

Study Start Up Specialist

TFS HealthScience26 open roles

Where
Warszawa, Poland
Work mode
Remote
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowStudy Start Up SpecialistTFS HealthScience · Warszawa, Poland

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on TFS HealthScience's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

13.9% of postings close within 7 days. Measured by our own scanner across the market. TFS HealthScience postings stay open a median of 14 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.7%3 days
  3. 13.9%7 days
  4. 22.4%14 days
  5. 38.1%30 days
  6. 59.0%60 days
This job: posted 31 hours ago

TFS HealthScience median: 14 days open

The posting

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Study Start Up Specialist, home-based in Poland.

About this role

As part of our CDS Dermatology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals.

As a Study Start Up Specialist, you will support the delivery of clinical trials by ensuring all study start-up activities are completed efficiently, compliantly, and within agreed timelines. Working closely with project teams, sites, investigators, regulatory authorities, and ethics committees, you will help maximize recruitment opportunities and support successful study activation.

Key Responsibilities:

  • Manage study start-up activities for assigned projects in accordance with timelines, protocol requirements, SOPs, and ICH-GCP guidelines.
  • Collect, review, process, and track regulatory and investigator documentation required for site activation.
  • Prepare and coordinate submissions and amendments to Ethics Committees/IRBs and support regulatory authority notifications.
  • Ensure the quality and completeness of all documentation included in submissions.
  • Adapt informed consent forms according to local regulations and company procedures.
  • Coordinate investigator contracts and support contract negotiations with internal stakeholders.
  • Participate in site identification, feasibility assessments, and site evaluation activities.
  • Maintain accurate and up-to-date start-up information within company systems and repositories.
  • Support Trial Master File (TMF) maintenance and ensure documentation is filed appropriately and on time.
  • Assist project teams with study set-up, site activations, status reporting, and project tracking.
  • Contribute to process improvement initiatives across Clinical Operations.
  • Support audit and inspection readiness activities.
  • Participate in project-specific responsibilities, including investigator payments, invoice tracking, financial reconciliation, and clinical study report support, when required.

Qualifications:

  • Bachelor's degree in Life Sciences or a related field preferred.
  • Minimum 1-2 years of SSU experience.
  • Solid understanding of ICH-GCP guidelines and applicable regulatory requirements.
  • Experience handling site start-up documentation and regulatory submissions.
  • Experience with CTIS submissions
  • Experience with site contracts negotiation
  • Nice to have: experience with MDR submissions.

What We Offer

We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Securing the Path from Science to Life

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against TFS HealthScience's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on TFS HealthScience's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    TFS HealthScience's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.