From 8th September 2021, you can find your dream job in our vacancies offer provided by Hobson Prior Agency. For example you can find there a job from location Hampshire, Southampton, United Kingdom functional area Science & Technology, position Clinical Project Manager.
A fantastic vacancy has become available for a Clinical Project Manager to join a drug and discovery development and biotech organisation on a permanent basis. If this is something you are interested in, please get in touch now! Please note that to be considered for this role you must have the right to work in this location.
*Key Responsibilities: *
* You will be the primary point of contact for internal staff and external vendors and to maintain a good line of communication between all parties. * You will be responsible for arranging and chairing regular study team meetings, to ensure the team are updated and any issues identified requiring cross functional input can be discussed and resolved. * To ensure the allocated clinical trial(s) is conducted according to the company and other agreed SOPs, the protocol and to international quality and safety standards (e.g. International Conference on Harmonisation Good Clinical Practice (ICH GCP), UK Statutory Instruments, EU Directives and revisions and any other applicable regulatory requirements). * To lead a clinical trial or certain aspects of a clinical trial to ensure the clinical trial(s) progresses at the optimal rate and that costs and quality are controlled as agreed with Senior Management, from study synopsis to clinical study report and study archiving. * To ensure that regulatory authority, research ethics committee and any other approval body (as required) approvals are obtained prior to the start of the clinical trial(s). * To put in place and maintain contracts and costings for all vendors involved in a clinical trial. * Specify and have agreed in writing the SOPs to which different aspects of the study (monitoring, data management etc.) should be conducted. * To maintain adequate oversight and good lines of communication with all vendors contracted to work on a given clinical trial. * To write the Clinical Trial Quality Plan for the allocated clinical trial(s). * Ensure all essential documents and processes are in place for the clinical trial(s) (e.g., project plan, risk management plan, clinical trial disclosure etc) * To liaise with Chief Financial Officer to ensure that the clinical trial insurance is in place in all the relevant countries and extends for the maximum duration of the study. To track clinical trial insurance and ensure this is always appropriate and in date. * To ensure all applicable trackers are in place and kept up to date for all clinical trials and to create or work with the team to create new trackers where required. * To oversee and track the following (this list is not exhaustive): site initiations, subject recruitment, data collection, data queries, essential documentation (either directly or via the vendor(s) contracted. * Assist with the identification of study sites and countries (if applicable) * To work with CRA's and Clinical Scientist teams, sites and vendors to resolve issues that arise during the trial, ensure activities in respect of the clinical trial are conducted in a timely manner and within the agreed timelines. * To oversee the provision and accountability of all trial materials (drug and non-drug supplies) and to be aware of expiry dates for the Investigational Medicinal Product (IMP) and other non-drug supplies as appropriate. * To ensure, in collaboration with the CRAs and the Clinical Trials Assistant (CTA), that the Trial Master File (TMF) is maintained in good order and that the documents are filed in a timely manner. * To ensure regulatory authorities, research ethics committees and any other approval body (as required) are informed as appropriate of all amendments, SAEs and study site closures and that the appropriate approvals are in place prior to implementation of the amendment. * Conduct co-monitoring visits to train and supervise the CRAs, and assist with monitoring as needed. * To report timelines, any problems or potential problems to the Senior Project Manager, Head of Clinical Operations and the in-house team as appropriate. * Assist the Chief Financial Officer with reconciling trial costs. * To educate, train and supervise other members of staff as appropriate, ensuring that good standards are maintained. * To acquire and demonstrate knowledge and skills, following the Company's standard operating procedures, applicable to the clinical trial(s). * To assist the Senior Project Manager and/or Head of Clinical Operations as requested. * Ensure that your workload is adequately covered in your absence, and to cover for colleagues in their absence. * To assist the with the writing and review of new, and existing, Standard Operating Procedures, as appropriate. * To ensure quality assurance within your role and to assist with audits / inspections as required. * Meet with your Line Manager and any other team member as required at a location, date and time agreeable to both parties. * Travel to clinical trial sites and the office in Southampton as required. * All work should be conducted in a manor satisfactory to ICH GCP and the regulatory bodies and in accordance with applicable SOPs. * Work must be conducted in a clean and safe working environment in accordance with the current version of the Company Handbook and with Health and Safety policies, including: infection control, risk management and fire safety. * To be able to work to and meet deadlines, managing your own time effectively whilst also being flexible to the clinical trial requirements. * To attend statutory training days, study days and company meetings necessary for the performance of the role and maintenance of your training file. * To maintain company confidentiality and IP and that of any clients / subjects at all times. *Requirements:*
* The ideal candidate will require a bachelors in life sciences with a preference for a masters additionally. * 2-3 years' experience in project management. * Experience in managing CROs and vendors. * Experience in Phases II and III. * Experience in respiratory is preferred. *Apply now*: If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.