Study Start Up Lead - Bucharest

Study Start Up Lead
Bucureşti
Bucharest, Bucharest, Romania

Job Overview

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or
- protocol programs, including
- award activities, oversight of the scope of work, budget and resources.

Essential Functions

Oversee the execution of Site Activation (including
- award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.

Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.

Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.

Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.

Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.

Provide overall guidance and oversight of
- regional and
- protocol programs during initial
- up and maintenance phase as an integral member of the study management team.

Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations

Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.

Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.

Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).

Mentor and coach colleagues as required.

Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.

May take a lead role in developing long standing relationships with preferred IQVIA customers.

Deliver presentations/training to clients, colleagues and professional bodies, as required.

May be involved in activities related to monthly study budget planning and reviews.

Qualifications

Bachelor's Degree Life sciences or related field Req

7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role.

Thorough understanding of regulated clinical trial environment and
- depth knowledge of drug development process

Good regulatory and/or technical writing skills

Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines

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

Informații detaliate despre oferta de muncă

Firma:	IQVIA
Localiția:	Bucureşti Bucharest, Bucharest, Romania
Adăugat:	28. 6. 2025 Postul de muncă activ

Răspunde la anunț
Fii primul, care se va înregistra la oferta de muncă respectivă!

Study Start Up Lead Bucharest

Study Start Up Lead
Bucureşti
Bucharest, Bucharest, Romania

Locuri de muncă Bucureşti - locuri de muncă interesante în împrejurimi:

Agent Call Center - Bucureşti, Romania - iCredit

Study Start Up Lead - Bucharest, Bucharest, Romania - IQVIA

Magazioner - Bucureşti, Romania - Flip

Manager Proiect - Bucureşti, Romania - Biroul de Traduceri INOVA

Business Intelligence Specialist - Bucureşti, Romania - Global HR Services

Area Trainer Formator - Bucureşti, Romania - Instore Power Provider

Consultant imobiliar - Bucureşti, Romania - VG Real Estate

Functionar Documentare - Bucureşti, Romania - EuroInterTrans

Receptioner Medical - Bucureşti, Romania - Clinica Retina

Reprezentant Vanzari - Bucureşti, Romania - Ortopedica

National Sales Manager - Bucureşti, Romania - Sterileco

SAP Sales/Account Executive - Up to 100% Remote from within The UK. - Bucharest, Bucharest, Romania - Eursap Ltd

Mecanic Auto - Bragadiru, Romania - Interactiv Service

Inspector resurse umane - Bucureşti, Romania - ECO GEODRUM

Inspector SSM - Studii Medii - Part Time - Bucharest, Bucharest, Romania - Playtech

Bucureşti: Alte locuri de muncă în orașul tău

locuri de muncă

Study Start Up Lead Bucharest

Study Start Up LeadBucureştiBucharest, Bucharest, Romania

Locuri de muncă Bucureşti - locuri de muncă interesante în împrejurimi:

Bucureşti: Alte locuri de muncă în orașul tău

Study Start Up Lead
Bucureşti
Bucharest, Bucharest, Romania