I’m working with a global big pharma business that are seeking a Global Study Manager to join the business on a 12 month contract.
This role will be responsible for all assigned studies – clinical operational oversight as well as the execution of monitoring of study deliverables, performing protocol-related site management activities, participating in study planning and set-up activities including vendor management, project management, coordination of study and implementation plans?and supporting third party vendor relationships.
Role Responsibilities include:
- Perform study management tasks as per agreed delegation/oversight by SrGSL/GSL.
- In partnership with internal experts and external service providers, provide oversight (as delegated by the SrGSL/GSL) 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).
- Adhere to SOPs, global process, applicable Quality & Compliance manual documents and international guidelines (e.g. ICH-GCP) to ensure study is inspection ready at all times.
- 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 Experience:
- Minimum 3 years’ experience working as a Clinical Project Manager in Phase I-IV studies within the pharmaceutical industry or a CRO
- Must have a background of leading studies within Cardiovascular, Renal, Metabolic or Respiratory and Immunology
- Must have experience working on global studies
- Strong vendor management experience
- Extensive experience in direct management of study start up activities
- Independent thinker with ability to anticipate issues and risks and to mitigate accordingly
- Team player who is able to prioritise workload in a fast-paced environment
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