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Clinical Operations Manager

Job Field:
CRM (Clinical Research Management) Jobs
Discipline:
Clinical Operations Jobs
Country:
Switzerland
Region:
Switzerland All
Contract Type:
Temp / Locum / Contract
Currency:
£
Salary:
50 to 100 per annum
Posted:
27-Nov-19
Recruiter:
Key People
Job Ref:
BBBH24699

An excellent opportunity has arisen to join a leading pharmaceutical company as a Clinical Operations Manager.

Please check boxes below:
□ Minimum 3 years of clinical research experience (within pharma or CRO) / at international-global level.
□ Coordinate the preparation and/or review of all operational trial-related documents (e.g., forms, guidelines).
□ Coordinate the preparation and distribution of the clinical study documentation (e.g., site communication, newsletters, pocket brochures, appendix 16 for the Clinical Study Report (CSR)).
□ Coordinate the delivery and inventory of study related non-clinical supplies (ordering, distribution, tracking, expiry dates management, resupplies).
□ Ensure completeness and maintenance of key trial information in the CTMS/eTMF.

REQUIRED QUALIFICATIONS AND EXPERIENCE
Experience and Knowledge
*Minimum 3 years of clinical research experience (within pharma or CRO) / at international-global level.
* Strong English written and verbal skills.
*Ability to work independently.
*Ability to effectively handle multiple priorities in a fast-paced environment.
*Ability to find effective solutions when faced with difficult situations and to implement team decisions.
*Strong computer skills, including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint).
*Some overnight travel (10%) may be required.

Behavioural skills
*Results-driven.
*Team player, ability to take initiatives.
*Detail-oriented and quality conscious.
*Strong organizational skills.
*Time management skills.
*Ability to work as an effective team member.

RESPONSIBILITIES AND TASKS
Assists the clinical operations team in the operational management and oversight of clinical trials, during set-up, conduct and until archiving, for an assigned trial.
*Coordinate the preparation and/or review of all operational trial-related documents (e.g., forms, guidelines).
*Coordinate the preparations and/or review of site related documents (e.g., Investigator Site Files (ISF).
*Coordinate the preparation and distribution of the clinical study documentation (e.g., site communication, newsletters, pocket brochures, appendix 16 for the Clinical Study Report (CSR)).
*Coordinate the delivery and inventory of study related non-clinical supplies (ordering, distribution, tracking, expiry dates management, resupplies).
*Coordinate site contracts finalization and execution.
*Coordinate Insurance certificates for the trial in collaboration with legal department.
*Ensure completeness and maintenance of key trial information in the Clinical Trial Management System(CTMS).
*File and upload documents in the different systems as needed.
*Ensure accurate maintenance, and archiving of the electronic Master File (eTMF) within the required timelines and contribute by performing ongoing quality checks/review.
*Function as a Study Owner in the eTMF when required.
*Assist in reviewing and providing feedback of Standard Operations Procedures (SOPs), Working Instructions (WISs) and processes.
*Schedule and organize functional group meetings and/or events as needed.
*Support the Clinical Operations group as needed, including the Global Strategic Sourcing Group (e.g. Contracts execution and shipment, Resource Request management, coordination of the providers contracts, processing of invoices in the system).
*Perform other duties as assigned.


Closing Date:
26/12/2019

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