Job Title: Clinical Study Manager
Job type:Full-time
Company: Stryker
Requisition ID: 24775BR-5359
Deadline: 25/08/2013
Division: Europe
Business Function: Clinical Affairs
Country: United Kingdom
City: Newbury
Job Description: The Job’s Mission
To manage the pan European clinical study process and activities relating to a specific product line, in close collaboration with relevant internal and external parties, ensuring that the European Union and Corporate protocols for clinical studies are adhered to in order to support the ethical and evidence based business claims within a specific franchise.
As well as supporting the clinical evidence requirements for reimbursement decisions that will enable Stryker to be viewed as a safe, reliable and compliant, cost effective partner of choice.
Key Activities & Accountabilities:
To develop, implement and manage the pan european clinical study program for a specific product line in close collaboration with the Clinical research manager and franchise.
Proactively partner with the franchise teams and CRM to understand potential new or improved product entry to the market and the requirement for clinical study data in order to prove the safety, effectiveness of product or support of marketing claims.
In collaboration with the identified Chief Investigator develop and implement the study protocol in line with local ethics committee requirements, European protocol guidelines and Company policy ensuring that all studies are conducted in a compliant and ethical manner.
Calculate the cost of the planned study, gain approval for the expenditure and manage all the end to end costs within time and agreed budget parameters ensuring a cost effective, ethical and results focussed, publishable study in order to support the franchise business requirements as well as pricing and reimbursement considerations.
Liaise with Clinical Contracts Associates and the legal team to develop and ensure the Implementation of the appropriate contract and inherent obligations that provides for and ethical, compliant study within the context of European, US legislation as well as Company contract Policy including but not limited to SOP 12.
Manage the requirements for gaining ethics committee approval including required protocol development, in close collaboration with the chief investigator in order to support the effective implementation of the study in single or multi site locations.
Design study-specific CRFs (Case Report Form) in close cooperation with Data Management.
Define the standards required within the study process including but not limited to training, CRF completion, data capture, serious adverse events notification.
Manage the whole clinical study process through to publication in cooperation with the responsible local CRAs in charge of the single study sites.
Plan and manage/facilitate all investigator meetings to ensure that study protocols and timelines are adhered to.
Proactively partner with the healthcare economics/ reimbursement team to ensure that the clinical data required for cost effectiveness evaluation is relevant and timely for their requirements.
Apply excellent ( best in class) conduct of clinical research studies.
Ensure an up to date knowledge of clinical study best practice and product knowledge as well as European legislative changes that may influence future study requirements relating to product or pricing.
Qualifications/Work Experience:
Experience Likely to already have at least 3 years post graduate work experience within clinical affairs, pharma or medical device industry.
Ideally with specific product knowledge although more important to understand clinical study methodology – through having worked perhaps as a clinical research associate/ senior CRA.
Familiar with according guidelines and standards.
Ideally experience of working with health care economists teams or at least a good understanding of the link between the two areas. Will have experience of working as part of a team, not just a single contributor.
Will be experienced in muliti cultural international environment either at work or through other interests or activities.
Will have had experience (at least 12m) of working with medical teams and Key Opinion leaders and be confident and articulate in their presence.
Will have either developed alone or can provide evidence of their ability to define and manage a budget for a clinical study.
Education Will have long term focus on the end result of achieving a full, throughout compliant clinical study, resulting in publications.
A disciplined and structured approach to clinical study management Financial acumen and the ability to define and manage budgets related to the clinical study lifecycle.
Will be able to demonstrate an ability to identify key stakeholders and develop and manage these relationships.
Will be able to demonstrate high integrity and the ability to say “no” to non compliant or potentially unethical behaviours or approaches.
Ability to understand and work with different personalities to align approaches and ideas in order to successfully set up and complete a study within agreed parameters.
Communication skills both written and verbal that allow them to express themselves clearly and articulately within different cultural environments. Fluent in English and the language of the host country.
Desirable but not essential – another European language.
Has an attitude that demonstrates a clear understanding of the opportunities to add value to an organisation and patients through effective, compliant,ethical clinical study management.
How to Apply: Click here
No comments:
Post a Comment