As a Director, Operational Strategy and Planning for our Clinical Development Services Group, you will provide senior leadership in the development and implementation our clinical operations strategic model, referred to as P3. You will partner with Business Development and Operations, through the design of evidence-based study plans, study engineering and study governance. In addition, this position will provide training and coaching to our clinical project teams on project strategy, risks and contingency planning.
Supervisor of Clinical Managers (CMs) accountable for their talent and career development including performance management. Facilitate allocation of Clinical Managers within and across Therapy Area (TA). Identify and establish best practices in trial operations and management. Develop headcount forecasts to support TA deliverables.
Responsible for the production of all Leeds costed proposals (Phase I, Early Clinical Development and Pharmacometrics) ensuring they are prepared in accordance with authorised methodology and meet the business needs.
As a Study Director at our site in Harrogate, North Yorkshire you will provide strategic and operational direction to designated studies to ensure that the scientific, technical and regulatory aspects are conducted in-line with the specified requirements. Working within our General Toxicology Department, you will be provided with the opportunity to utilise your highly developed study management skills to handle a range of responsibilities.
You will be managing a team of committed Contracts Associates. Mentoring, coaching and training. Providing strategic and technical direction. Conducting contract management tasks on high complexity projects. And taking the lead on developing processes and service quality.
Due to the continued growth of the business, an exciting new opportunity has arisen within (OSI) Prosidion's Biology and Pharmacology Group, based in Oxford, UK. In this newly created position you will establish and lead a functional group, consisting of PhD level and graduate biologists, responsible for assay development and the implementation of in-house screening assays and assay transfer to the Lead Discovery Group.
Due to the continued growth of the business, an exciting new opportunity has arisen within (OSI) Prosidion's Biology and Pharmacology Group, based in Oxford, UK. In this newly created position you will establish and lead a functional group, consisting of PhD level and graduate biologists, responsible for aspects of molecular pharmacology including target localisation studies, functional assays in endogenous cell lines and isolated tissue work.
Reporting to the Senior Director, Pharmacovigilance, the Director, Pharmacovigilance & Risk Management Report Writing will be responsible for medical writing, management of reference documentation, training and quality control associated with aggregate report writing in pharmacovigilance. Activities include the preparation and expert oversight in the preparation of company Periodic Safety Update Reports, Risk Management Plans, responses to regulatory enquiries and ad hoc safety reports.
Provide functional leadership for all medical activities for UK & Ireland, including: medical support for the commercial activities of Shire HGT, championing modern ethical medical marketing practices, forging relationships with both national and, as appropriate, international Key Opinion Leaders (KOLs), provide scientific input and attend regional and national congresses, participate in external expert groups integral to the successful management of Outcome Surveys, including National Boards and as appropriate Working Groups.
Assist in the management of process improvements by communicating, as appropriate, current knowledge of new and/or revised regulations and industry best practices; review audits, the QA audit database and assess audit trends; respond to process and vendor audits and collaborate with other R&D functions in supporting the audit response process to ensure that appropriate corrective and preventive actions are put in place. Manage and improve the process for preparation and review of R&D SOPs and other required documentation such as informed consents and protocols.
Foster cooperation and improve working relationships within R&D by responding to issues and concerns and provide advice and support consistent with company and R&D policy. This may include: the review and monitoring of audit reports, the QA audit database and audit trends to identify gaps, perform gap analyses, root cause analysis, recommending solutions for process improvement, collaboration in order to implement process improvement activities.
Advise and support International Commercial leadership and local operating company Medical Directors in ADHD therapeutic area, assuring alignment of medical and scientific ADHD brand strategy and tactics with US and across countries.
Primary role is to gain new business for PAREXEL in hitherto un-tapped Customers/Accounts or in existing Customers/Accounts. May also be called upon to support other members of the Worldwide Business Development team, operating in the Established Account Development Role, to widen penetration of existing Customers/Accounts.
Manage the scope of work, objectives, timelines, quality of deliverables, and all other project management activities for the project(s) or program. Serve as primary project contact with Sponsor to ensure appropriate communication channels are maintained and reporting schedules adhered to.
Manage the execution of the clinical component of large, complex study protocols including cross regional / global projects and multi-protocol programs in accordance with the scope of work, contracted timelines and study budget. Direct other Project Coordination Centre (PCC) Leads assigned to the same project. May also serve as combined Project Manager / PCC Lead / CTL on regional or international projects.
We are currently recruiting for a Director of QA this role will be to oversee and coordinate the quality assurance program for assigned customer projects at a regional and/or global level. Provide support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures among sites within the region and globally as assigned. Act as line manager for one or more QA staff. Serve as primary back-up for QA management.
Responsible and accountable for owning and driving the contracts process for assigned customers with a primary focus on Customer satisfaction with Quintiles’ contracting process. Responsible for developing relationships with assigned customers and assuring high quality deliverables and customer service.
Oversee the Management of the scope of work, objectives, quality of deliverables, and other project management activities of all projects, which may be multi-regional or global in scope and cover a number of therapeutic areas.
Manage a team of remote monitoring staff in one or more sites within a region. Work with country/region leadership in formulating effective strategic goals and objectives for designated region and assure operational alignment with senior management priorities. Ensure that clinical Project Coordination Centre (PCC) staff gain the necessary skills to perform their respective job responsibilities. May also supervise Managers, PCC.
This role is key in directing, supervising and managing large, global, complex, multi-regional, late phase, full service project or multi-project programs to the Sponsor’s satisfaction, ensuring quality deliverables on time and within budget.
Manage the scope of work, objectives, timelines, quality of deliverables, and all other project management activities for the project(s) or program. Serve as primary project contact with Sponsor to ensure appropriate communication channels are maintained and reporting schedules adhered to.
Generates sales (of net revenue) from assigned customers to achieve individual and team targets. Assists with the creation and implementation of customer plans, for assigned customers that embody global product development account team goals.
Involves line management responsibilities including professional development, performance appraisals, and mentoring junior staff. Reviews workload for all direct reports. Establishes goals that will increase knowledge and skill levels by providing input on delegating tasks commensurate with skill level.
Helping to drive strategy/business planning to ensure an increase in market share for Quintiles. Providing drug development expertise to support strategic business activities. Ensuring Customer Satisfaction by working closely with Senior Management, and other Operations Heads to ensure optimum consultancy to customers.
Generates sales (of net revenue) from assigned customers to achieve individual and team targets. Assists with the creation and implementation of customer plans, for assigned customers that embody global product development account team goals.