Company: ProClinical Ltd
Closing Date: 21 Oct 16
Salary (£): Competitive
An internationally known biotechnology company has an opening for a Early Phase Contract Clinical Study Manager job at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide. Job Role:Partnering with the Study Lead Scientist (e.g. ...
An internationally known biotechnology company has an opening for a Early Phase Contract Clinical Study Manager job at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide.
Partnering with the Study Lead Scientist (e.g. Medical Director, Pharmacologist, Biomarker Science Leader) and other functions to develop operationally feasible and clear protocol concepts and final protocols. Leverage early phase operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level operations strategy.
Independently oversees and leads one or more early phase clinical studies by establishing the operational strategy and securing excellence in execution and delivery through the CROs and vendors.
Identifies strategic operational approaches that span program(s) partnering with the AD ECDOL and drives the evaluation and implementation as appropriate.
Positively impacts the performance of other Early Development Operations Study Leaders by, for example, initiating and leading discussions at peer level forums relevant to the Sr ECDOL role and development in line with Early Clinical Operations best practices.
1. Ensures delivery of early phase clinical studies (Scientific Research Collaboration (SRC), clinical pharmacology, Phase 0, Phase 1/1b and phase 2 through POB/POC) on time, with high quality and within agreed budget by:
- Partnering with the Study Lead Scientist and other functions to develop scientifically robust, operationally feasible and clear protocol concepts and protocols.
- Utilizing operational expertise and scientific assessment to evaluate study feasibility.
- Developing study operational strategy and risk mitigation plans in alignment with the clinical development plan and program operations strategy.
- Define and implement the sourcing strategy for the study.
- Leading/chairing the cross-functional Study Management Team and ensuring that all the supporting functions across the company are involved in the planning and implementation of the study are effectively contributing to study delivery; ensuring the proactive identification and resolution of issues across those functions.
- Overseeing the tactical execution of the study operational strategy by the CRO(s).
- Selecting the study sites and strategically building strong relationships with investigators and investigational site staff.
- Building a rich knowledge of specific Area(s) of Expertise specific to the conduct of early phase clinical studies. They are a mentor / SME for the Early Clinical Operations group and leveraged by other groups within ECD and across Development Sciences for their early phase operational expertise.
Strives for effective, fit for purpose, efficient and compliant processes by:
- Leading and/or contributing to the functional initiatives within ECO, ECD and Dev Sci.
- Following established procedures and SOPs while seeking ways to improve and adapt processes to support the conduct of different types of studies within the early phase space.
- Embodying a culture of continual improvement and innovation by actively seeking new ways of working more efficiently to meet the needs of Early Clinical Development.
- Championing best practice development in the planning, conduct and reporting of early phase clinical studies and seeking opportunities for innovation and efficiency within the Early Clinical Operations group by actively sharing knowledge and experience
- Seeking interdependencies and synergies with other trials and programs to enhance superb planning and execution across studies in Early Clinical Operations.
- Good general knowledge of clinical development with a good understanding of the early clinical development phase including its objectives and specificities.
- Interested in science and able to scientifically understand protocols.
- Ability to establish study operational plans and to ensure their execution by leading the cross-functional team and overseeing the CROs and vendors. Requires a balance of scientific and operational/project management and team leadership expertise. Must be able to build effective relationships across and up and down the organization.
- Ability to adapt to different operating models and to quickly shift strategy based on new information.
- Inquisitor and comfortable with the unknown.
- Ability to leverage rapid turnover of studies.
- Ability to operationalize studies with new indications or patient populations, novel endpoints and new procedures.
- Ability to influence the Lead Study Scientist on clinical study direction based on changing internal and external landscapes within a disease or therapeutic area
- Excellent project management skills, including risk assessment and contingency planning.
- Able to partner with other functions and both internal and external stakeholders.
- Excellent leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills.
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
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 0207 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.
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