Associate Manager, Study Start-Up (FSP)

Parexel International Corporation

United Kingdom - Any Region - Home Based

Working as an Associate Study Start Up Manager at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Our key oncology biotech sponsor is building a brand new SSU function in Europe from the ground up, and we need SSU professionals to help them across the EU.

Some specifics about this advertised role A rare opportunity to help build an SSU function Dedicated to one client. Accountable for site start-up for 2 or more clinical studies. Serves as primary point of contact (POC) and escalation for site start-up on assigned clinical studies. Holds start-up Kick Off Meeting with Manager, Study Start Up, European Union (EU), Protocol Lead (PL), Clinical Contracts Manager (CCM), Legal, and other key stakeholders. Holds weekly start-up meetings with Manager, SSU, EU, PL, CCM, Legal, and other key stakeholders as necessary. Forecasts and tracks progress of site start-up, ensuring all sites on assigned clinical trials are greenlit on time per study start-up timelines. Escalates site issues to appropriate Clinical Study Team members. Attends Clinical Study Team Meetings through start-up. Prepares and updates start-up packets for clinical studies Assigns sites to Study Start Up Specialists, manages Study Start Up Specialist and Study Start Up Assistant workload for assigned studies. Ensures Study Start Up Specialists collect, review, and track essential documents, and review informed consent forms (ICFs) in accordance with Client processes and timelines. May have the following indirect management responsibilities: Problem-solving clinical team personnel issues. Manages dotted line Study Start Up Specialists and Study Start Up Assistants. Providing timely feedback to Study Start Up Team staff on personal and project-specific performance. Train and mentor junior Study Start Up Team members

Study start up at Parexel FSP

Parexel FSP supports clinical studies across the full range of oncology and non-oncology therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

On a human level, if you’re a SSU professional with a passion for a particular therapeutic area, we’ll do our best to accommodate you. Or equally, we can help you broaden your experience.

You’ll be an influential member of your team really working with the sponsor to help develop the function.

As well as learning by osmosis from industry-leading professionals, you’ll gain world class training from Parexel and from our sponsors too.

And you’ll be able to share knowledge and ideas with a global community of clinical operations, biometrics, regulatory, medical writing, and medical affairs specialists.

As you close one site, there’ll be many more opportunities open to you, at the top of your profession.

We value work-life balance. We aim to keep regular hours and an emphasis on life outside the office. We’ll value your welfare just as highly as that of our patients. Our managers will listen to, and act on, any concerns.

QualificationsWhat we look for in Associate SSU Specialists Bachelor’s degree in nursing, Life Sciences or Medical Sciences or equivalent work experience required. C4 years within a similar role Experience on ICF country level creation, country customization, knowing the requirements and guidelines per country. Experience submitting to ECs. SSU team will be involved on the package preparation and submission execution to CEC/LEC/ Part II and local specific authorities. Effective time management, organizational and interpersonal skills & problem-solving skills, with the ability to multi-task and prioritise.

Not quite the role for you?

Don’t worry we need experienced professionals for different locations, sponsors, and therapeutic areas, and at entry, mid and senior levels.

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2022-06-21 00:05:16

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