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Job Details

Global Senior Study Manager - Oncology

Company: ProClinical Ltd
Location: Espoo
Reference: CR.PL.14856
Closing Date: 25 Jan 18
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

ProClinical is working on an amazing job opportunity for a Global Senior Study Manager - Oncology at a multinational pharmaceutical company based in Espoo, Finland. With over 5000 products, found in virtually every area of human activity this company is associated with some of the leading brands around the world. ...

Requirements:

ProClinical is working on an amazing job opportunity for a Global Senior Study Manager - Oncology at a multinational pharmaceutical company based in Espoo, Finland. With over 5000 products, found in virtually every area of human activity this company is associated with some of the leading brands around the world.

This Senior Study Manager role will manage and be responsible for all aspects of assigned Phase I - IV global and complex local clinical trials, within the approved Clinical Development Plan (CDP). In comparison to the Study Manager the senior Study Manager typically assumes responsibility for more complex, bigger and/or higher priority programs. Due to their level of expertise in the role they may also act as a mentor to junior or less experienced Study Managers.

Job Responsibilities:

* Plan and manage highly complex and/or strategic priority clinical studies; characterized by challenging protocol/study designs, atypical study operations, high study financial costs, large global clinical trial scope and/or new areas of investigation
* Manages and is responsible for all activities related to global and/or local clinical trials from the study concept to the clinical study research report
* Leader of the Study Team, from the request of core Study Team members to study close-out contributes to the Study Concept development with regard to its operational aspects, if assigned already
* Develops the comprehensive overview and operational plans for the study by developing and maintaining the Study Plan
* Contributes to risk management activities of GCT and responsible for study specific oversight and risk mitigation activities as described in the Study Plan
* Supports strategic study feasibility and manages operational study feasibility conducted by country organization to determine study feasibility and final country selection
* Based on the feasibility summary, develops study timelines, milestones, outsourcing plan and proposed external study budget
* In close collaboration with the study team assists in the development of the core study documents and processes
* Assists in the preparation of the study protocol
* Responsible for developing the total external study budget and accountable for providing monthly and yearly estimates
* Responsible for tracking study budget, initiating payments, forecasting and providing monthly information to controlling and GCL, identifying budget/estimate issues
* Ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT
* Identifies, implements, leads and manages a cross-functional core Study Team for the duration of the study, working with functional line management to identify team members and resolve issues. The Core study team members include: Study Medical Expert, Study Statistician, Study Data Manager and the Study Lead Monitor disseminates relevant information to team members in effective and timely manner
* Represents the study team as a member of the Global Clinical Team
* Manages, tracks, and is responsible for ensuring ongoing study activities, study execution and timelines are met
* Tracks and compiles patient enrolment, data cleaning progress and overall study progress
* Assesses and analyses study information for variances and takes necessary actions within his/her responsibility to resolve variances, if necessary
* Initiates action with functional heads to resolve variances

Skills and Requirements:

* The incumbent must have a Bachelor’s degree or equivalent education with 8+ years of relevant healthcare experience which includes 5 years clinical operations in the pharmaceutical industry including direct monitoring and clinical trial/study management experience.
* Of the 5 years of clinical operations experience, 3 years of monitoring experience and 2 years of study management experience.
* Strong oncology experience in needed.
* The position also requires awareness and understanding of cultural differences as well as regional operational differences.
* The incumbent requires comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters.
* Effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, and excellent interpersonal, decision-making and issue resolution skills are required.
* In addition, the incumbent requires effective planning and organization skills, attention to detail and excellent follow through.
* The senior Study Manager can manage conflicts in the team effectively.



To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Global Senior Study Manager - Oncology

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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