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Job Details

Clinical Project Manager - Medical Affairs

Company: ProClinical Ltd
Location: London
Reference: CR.MP.15383
Closing Date: 26 Feb 18
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

ProClinical is seeking a Clinical Project Management, Medical Affairs, for a global pharmaceutical company with a therapeutic focus. The Manager is an essential position within GMAF SMDA focusing on leading day-to-day management activities across assigned trial(s) to ensure high quality deliverables. ...

Requirements:

ProClinical is seeking a Clinical Project Management, Medical Affairs, for a global pharmaceutical company with a therapeutic focus. The Manager is an essential position within GMAF SMDA focusing on leading day-to-day management activities across assigned trial(s) to ensure high quality deliverables. The Manager is responsible for the implementation of study(ies) across the study lifecycle, including but not limited to protocol development, study oversight (timelines, planning, and budgets), quality, compliance, meeting facilitation, and vendor management.

Job Responsibilities:

* Responsible for vendor selection, management and definition of performance metrics in collaboration with cross-functional business partners
* Accountable for vendor performance, communication of expectations, and tracking of performance metrics at a study level
* Trial Oversight and Essential Documents
* Develop and manage the budget for assigned trial(s), including tracking monthly spend against planned, and provide GMAF SMDA leadership with updates
* Accountable for the development and management of detailed timelines for assigned trials(s)
* Facilitate short and long-term planning for assigned trial(s)
* Facilitate and manage monthly study team meetings, including review and approval of agendas and minutes and distribution of study updates within team
* Define the country and site selection strategy and country-level feasibility assessment
* Collaborate with the Medical Directors and/or Medical Science Liaisons to support site and/or Ethics Committee questions about assigned trials(s)
* Participate in the writing of study documents, including but not limited to protocols, informed consent document templates, regulatory reports, statistical analysis plans and study reports
* Approve the study-level plans, including the monitoring plan
* Responsible for trial master file (TMF) activities including establishing the TMF plan, managing the reconciliation process, and providing study-level content for filing into the TMF
* Accountable for the final review of the site-level documentation and approval for initiation
* Accountable for product forecasting across all supply chain activities, including shipment and reconciliation
* Accountable for the development and utilization of metrics and management reporting tools for efficient trial execution
* Responsible for participating in the design and utilization of data review tools and data collection initiatives by assigned Study Team members, and resolution of identified issues

Skills and Requirements:

* Distilling complex issues to simple terms, while driving information dissemination up and down the organization to influence appropriate outcomes
* Ensuring that team roles and responsibilities are clearly defined, understood, and fulfilled
* Contributing to the development of a motivating team/work environment by upholding positive morale and encouraging high performance
* Demonstrating an ability to recognize, understand, articulate and respond promptly to issues that arise, escalating as appropriate
* Demonstrating robust knowledge of GCP and GVP guidelines and their impact on each stage of the trial (start-up through close-out)
* Ability to identify and mitigate compliance risks across a clinical trial
* Demonstrating command of site management and trial oversight
* Demonstrating an ability to lead efforts in identifying and selecting vendors for assigned clinical trials
* BA/BS or higher in life or health sciences preferred. Industry or relevant experience in lieu of education accepted
* 5 years of relevant experience in clinical science, clinical trial or site management, medical affairs, and/or drug development
* Some line management experience (0-1 years) preferred
* 8+ years’ experience in clinical drug development in pharmaceutical or biotech environment. Extensive knowledge of clinical trial documentation including monitoring experience, regulatory agency requirements and operational aspects of clinical trials/registries.
* Excellent oral, written and interpersonal skills.
* Ability to manage the operational aspects of one of more MAF SM sponsored studies.
* Timeline development utilizing MS Project, budget development experience and a history of line management required.
* The Manager is expected to manage up to 2 direct reports; actual number of direct reports may vary depending on business needs

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 Matthew Pike on +44 207 4400 639 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: Clinical Project Manager - Medical Affairs

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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