Global Clinical Study Manager
A vacancy has become available for a Global Clinical Study Manager, this is a home-based role at a large pharmaceutical organisation. You will be expected to work cross functionally to ensure study delivery.
- In partnership with internal experts and external service providers, provide oversight to ensure study delivery of both internally-run and outsourced studies.
- Lead/contribute to the preparation of delegated study documents (e.g. Informed Consent Form, applicable study plans, etc.), and external service provider-related documents (e.g. specifications, study specific procedures, etc.)
- Maintain and facilitate interactions with both internal & external functions to ensure efficient study delivery to time, costs and quality objectives.
- Manage the set-up and maintenance of third-party vendors.
- Support the SrGSL/GSL with budget management. Initiate contract/budget requests for third-party vendors, facilitate generation of purchase orders, track spend against approved budget and manage the change order process.
- Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
- Contribute to the planning and conduct of internal and external meetings.
- Ensure adequate supply of study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
- Proactively contribute to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
- Ensure that all study documents within scope of the GSM's responsibilities are complete and verified for quality in the Trial Master File (TMF).
- Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their line manager. May act as Subject Matter Expert for a particular process or system within Study Management Early.
Skills and Requirements
- University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research.
- Relevant pharmaceutical industry and/or clinical trial experience.
- Deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development.
- Proven organisational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
- Demonstrated ability to work well both on a cross-functional team and independently
- Strong collaborative communication skills (verbal & written) in English
- Ability to prioritise appropriately and to be adaptable
- Demonstrated leadership skills
- Computer proficiency in day-to-day tasks
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.