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

Open nowFirst seen 3 days ago

Global Study Manager - FSP - UK - PACT/MAP experience

Lifelancer3,724 open roles

Where
Remote
Work mode
Remote
Get the CV for this job

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

Your applicationOpen nowGlobal Study Manager - FSP - UK - PACT/MAP experienceLifelancer · Remote

  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 Lifelancer'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.

12.1% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.1%7 days
  4. 19.1%14 days
  5. 35.6%30 days
  6. 52.7%60 days
This job: first seen 3 days ago

The posting

Job Title: Global Study Manager - FSP - UK - PACT/MAP experience

Job Location: Remote, United Kingdom

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Global Study Manager – This position is a fully client-embedded role, dedicated to a leading bio-pharma company. Successful candidate must have PACT/MAP experience.

Role Purpose:

This position accountable for delivering the clinical operation activities of the study until study archiving. This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality. The GSM role works in consultation with the Global Study Lead for end-to-end delivery of the clinical study.

Key Responsibilities:

- GSM will be accountable for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision -making at pace and leading study team to achieve overal study deliverables

- GSM is accountable for the following deliverables:

  • Study Initiation Meeting
  • Clinical Study Activity Plan
  • Study Delivery Plan
  • TMF Quality Strategy Document
  • DCT Set Up
  • Vendors Oversight Plan
  • Investigator/CRA Meeting Set Up & associated training
  • Recruitment Tracking
  • Budget tracking eTMF filing and Vendor Set Up and Management
  • Safety Management plan
  • eTMF & vendor set -up ​

- Proactively and effectively identifies, oversees, and mitigates study risks

- Ensures appropriate stakeholder communication, including study status,

expectations, risks and issues

- Accountable to operate within the study budget

- Effectively leads empowered matrix teams

- Responsible for operational input into protocol and informed consent form

development, and other key study documents.

- Leads and conducts investigator meetings and other study related meetings

- Leads quality efforts to ensure protocol compliance and continual inspection

readiness for assigned studies

- Oversees the activities of the countries participating in the study

Education Requirements:

- Bachelor’s degree: life sciences or related discipline; The role will require a good understanding of complex clinical development and regulatory processes.

Role Related Experience:

  • At least 5+ years of relevant study management experience on a global level.
  • Previous experience with PACT/MAP
  • In-depth experience in clinical research: study management, monitoring, data management
  • Must have exposed to clinical study management “end-to-end” Globally : NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset –
  • Must have proven experience from study feasibility to CSR
  • Must have at least Ph II and PIII experience – PI & PIV is an asset
  • Must have cross-functional leadership proven experience, able to drive internal and external meeting
  • Able to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systems
  • Strong experience in clinical budget management
  • Strong experience with vendor management including CRO
  • Exposed to competent authority Inspections (FDA, EMA, MHRA, PMDA...), being involved in studies pivotal for drug file registration is an asset
  • Fluent in English, to the level they can negotiate and discuss (adapt message) related to complex topics with any Clinical team member (Local country representative, Statistician, Data Manager, laboratory, central laboratory, Scientific writer, safety representative, study Phycician and any type of vendors as well as able to present clear status to upper management if required.
  • Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.
  • Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
  • Strong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
  • Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

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 Lifelancer'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 Lifelancer'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

    Lifelancer'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.