DOCS Global

Project Specialist

Poland (office
24 May 2021
18 Jun 2021
Project Management
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Project Specialist

The PS is a member of extended global study team supporting delivery of clinical studies 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 PS works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Project Manager/ Project Leader in delegated aspects of clinical study execution in accordance with the Study Team Operating Model (STOM), Project Management Framework, current clinical trial regulations (e.g. ICH GCP).

Typical Accountabilities
• In partnership with enablement team, other clinical experts and external service providers, the PS provides oversight to ensure study delivery.
• 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 including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient
Safety and Quality Assurance, 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 Project Specialist responsibilities are complete and verified for quality in Trial Master File
• Supports Project Manager / Project Leader 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 Project Manager / Project Leader in project management as per agreed delegation
• Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager

Education, Qualifications, Skills and Experience
• 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 on similar position (Study Coordinator, global CTA, in-house CRA, Project Specialist)
• 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
• Experienced in supportive project management
• 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


Similar jobs

Similar jobs