Global Study Manager - FSP - EMEA

Location: Remote, Bulgaria

Category: Clinical Research

Employment Type: Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Global Study Manager/Global Study Lead – This position is a fully client-embedded role, dedicated to a leading bio-pharma company.

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.

• In-depth experience in clinical research: study management, monitoring, data management

• Previous in-depth Oncology experience

• 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)