Global Study Manager - Single Sponsor dedicated (in EMEA)

IQVIA; Oeiras; On-site; EUR 39,000 - 93,000; Full time

Job summary

IQVIA in Portugal seeks a Global Study Manager to support the delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management, from CSP development to CSR and study archiving.

The GSM collaborates with client teams and CROs to ensure on-time, on-budget, high-quality study delivery, managing documents, budgets, risks and QA in line with ICH/GCP and SOPs.

Qualifications

• University degree in medical or biological sciences or related field.
• At least 3 years of pharmaceutical industry or equivalent experience.
• Knowledge of clinical development and drug development processes.
• Excellent knowledge of ICH/GCP guidelines.
• Strong communication and relationship-building with external providers.
• Good project management skills.
• Ability to collaborate and work independently.
• Excellent English verbal and written communication.

Responsibilities

• Lead preparation of delegated study documents and external provider docs.
• Maintain interactions with internal and CRO partners to deliver study objectives.
• Plan and conduct internal and external study meetings.
• Ensure supply of Investigational Product and study materials.
• Contribute to risk identification and mitigation planning.
• Verify study documents in the Trial Master File.
• Support budget management and invoice reconciliation.
• Adhere to ICH/GCP and Quality & Compliance manuals.
• Oversee CRO project management for outsourced studies.

Skills

Communication

Leadership

Project management

Collaboration

Independent working

Computer skills

English proficiency

External vendor management

Education

University degree in life sciences

Tools

ICH/GCP knowledge

SOPs proficiency

Job description

Job Overview

The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clincal Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving.

The GSM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Global Study Director (GSD) or Global Study Associate Director (GSAD) in delegated aspects of clinical study execution in accordance with the Delivery Model.

In partnership with client's team,

Essential Functions

• Leads/contributes to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.).
• Maintains and facilitates interactions with internal functions and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.
• Contributes to the planning and conduct of internal and external meetings (e.g., Investigators’/Monitors’ meeting).
• Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
• Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
• Ensures that all study documents in scope of GSM’s responsibilities are complete and verified for quality in Trial Master File.
• Supports GSD and/or GSAD with budget management, such as external service provider invoice reconciliation.
• Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.
• Supports GSD and/or GSAD with overall project management as per agreed delegation.
• For outsourced studies, supports GSD and/or GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant client’s SOPs and guidelines (e.g., description of services and transfer of obligations)

Internal BioPharmaceuticals Clinical Operations Job Description

relevant client’s SOPs and guidelines (e.g., description of services and transfer of obligations)

• Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager

Qualifications

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
• Knowledge of clinical development / drug development process in various phases of development and therapy areas
• Excellent knowledge of international guidelines ICH/GCP
• Excellent communication and relationship building skills, including external service provider management skills
• Good project management skills
• Demonstrated ability to collaborate as well as work independently
• Demonstrated leadership skills
• Computer proficiency, advanced computer skills in day-to-day tasks
• Excellent verbal and written communication in English

Please note this role is not eligible for the UK visa sponsorship.

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is 171.500,00 zł - 404.600,00 zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part‑time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.