Due to expansion, we are seeking motivated and inspiring individuals who wish to broaden their career. If you wish to be part of an exciting, dynamic company at the forefront of global Clinical Research and you are looking for a permanent or freelance position located at home or office based then please contact our Resourcing team.
EMAIL: careers@clintec.com
PHONE:
+44 (0) 141 945 6960
CURRENT VACANCIES
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A prestigious opportunity has arisen for a professional and ambitious MBA graduate to join our Corporate Development team at ClinTec International. Some of the responsibilities of the Corporate Development Executive will include evaluating commercial opportunities to expand the ClinTec International group, negotiate and form corporate structures through the formation of joint-ventures, acquisitions, mergers with companies internationally and responsibility for carrying out investment proposals and pitches to shareholders and external financiers in order to mobilise new ventures. The job holder will work closely with Senior Management / Board Members. Diplomacy, professionalism, negotiation and commercial awareness are key skills necessary in this role as well as MBA Graduate (or studying towards) together with Hons degree in any discipline
Monitor specified sites to ensure quality and intergrity of data, compliance with relevant SOPs and regulatory requirements Acting as the central contact for all members of the Clinical Project Team for the transmission, collation, tracking and filing of project documents Assisting the Project Manager in facilitating verbal and written communication between Project Team members REQUIRED EXPERIENCE, SKILLS & ABILITIES; Educated to degree level and prior experience as a CTA is preferable Basic training and experience within the clinical trials arena Some knowledge of FDA/ICH regulations, drug development and clinical monitoring procedures Fluency in the English language is essential as well as strong planning, communication and organisational skills including verbal and written Strong computer skills with regards to email, Mircosoft Word and Excel are necessary
RESPONSIBILITIES INCLUDE; Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures Site management to ensure proper adherence to protocol, source data verification and assess CRF entries Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists Assist with study protocol design, development and / or review if required Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required Perform pre-study initiation, interim monitoring and close out visits as required Carry out drug formulation administration procedures and documentation records Ensure adequacy of drug shipment and drug accountability Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required Organise / attend investigator meetings as require Provide support to the Project Manager / Country Manager with ad-hoc tasks as required
Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline Clear understanding of the drug development process Significant experience in performing a Clinical Research Associate role Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials Ability to contribute to the development of clinical trial related documents and materials Ability to independently perform pre-study initiation, interim monitoring and close out visits as required Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail Fluency in English language (both written and spoken) Fluency in relevant language (both written and spoken) Willingness and ability to travel up to 60% of the time Willingness and ability to work in relevant country
Experience across a wide range of clinical indications / therapeutic areas Ability and experience to work with an electronic case report form (eCRF) Membership of local professional bodies or international clinical groups Ability to mentor, train, supervise and inspire confidence in newcomers to the industry
Lead one or more projects concurrently to a successful conclusion by effectively managing the project team to meet milestones / deliverables whilst adhering to budget and agreed timescales Demonstrate and promote understanding of contract terms and scope of work; Identify changes as required, work with team members to quantify impact, agree and process change requests where necessary Monitor and review the study in terms of financial progress, business analysis and services and compare to milestones delivered Resolve any discrepancies in terms of budgeted costs or contractual issues in a timely fashion and with minimal disruption to services provided Develop project schedules of tasks with input of project team members; identify responsible parties, staffing needs, and timeframe for completion of project with list of deliverables, plan timeline in concert with client commitments Communicate regularly with senior management and client on progress of project as well as ensuring studies are conducting following protocol and complying with ICH-GCP, ethical and regulatory standards Travel periodically to sponsor and sites as needed and perform other related duties as assigned REQUIRED EXPERIENCE, SKILLS & ABILITIES Good understanding of ICH GCP and regulatory requirements and of the clinical research process. Demonstrated ability to conduct the majority of clinical monitoring activities effectively, efficiently and with the minimum of supervision
RESPONSIBILITIES INCLUDE; Leads the planning, scheduling, and coordination of global and/or regional clinical trial applications during development and product lifecycle, based upon thorough knowledge of applicable regulations Enforces the clinical trial application strategy and contributes to the clinical trial submission plan for all assigned trials Represents Clinical Monitoring in clinical trial teams Manages the review and technical approval/sign-off for clinical trial applications for Health Authorities and Ethics Committees and documents for assigned trials, liaising with other functions as appropriate Submits high quality, “Right First Time” clinical trial applications based on agreed timelines with the various functions to achieve approval with minimal delay Contributes to the prediction of questions be Ethics Committees and Health Authorities and contributes that these are addressed for future applications to achieve approval with minimal delay and maximum of quality Ensures the implementation, maintenance and continuous improvement of the submission process to Ethics Committees and Health Authorities in the regions Contributes to activities to achieve regulatory compliance Liaises with Global Regulatory Affairs to ensure accurate, high quality and timely preparation of the related documents for submission to Ethics Committees and Health Authorities Identifies appropriate resources required to support regional and/or global submission activities Contributes to a high profile interface with associations and external groups to increase the company’s influence and knowledge on clinical trial applications worldwide REQUIRED EXPERIENCE, SKILLS & ABILITIES MD, MS or Ph.D. degree in a science-related field with strong experience in Drug Regulatory Affairs or equivalent combination of education with a demonstrable track record in drug development /regulatory experience Demonstrated track record of clinical trial applications to Ethics Committees and Health Authorities Ability to understand, manage and lead in a multi-cultural atmosphere Strong leadership and management skills with cross-functional teams Strong project management and process improvement abilities Comprehensive experience with clinical trial procedures and requirements in the regions Excellent interpersonal communication, organizational and presentation skills Superior negotiation and influencing skills Fluent command of spoken and written English Acceptance to travel nationally and internationally |
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Our operations are continuously expanding and the needs of our business are evolving therefore we are always happy to accept applications from experienced Clinical Research Professionals at all levels, please e-mail your CV to careers@clintec.com
NO AGENCIES, THANK YOU
providing a helping hand in clinical research