Clinical Trial Manager

Job Description

You will oversee international trials, oversee CROs and interface with healthcare professionals, clinical investigators, regulatory agencies and internal stakeholders.Client DetailsMy client aim to be the worlds leading consumer health tech brand by making a real difference to human health and wellbeing. They will bring healthcare into the home and combine cutting edge technology with a consumer-first approach. As a company, they are consumer-focused with global ambitions, founded by an experienced team of industry veterans, entrepreneurs and scientists. They have ground-breaking technology that truly empowers the consumer and are hiring now to build our initial development team. Description* Help develop and manage internal and external clinical trials* Track and manage clinical budget expenses* Maintain database of opinion leaders and contacts* Manage and support investigator-initiated research* Manage research operations including documents (protocol, CRF, IFC, patient facing materials, and more as needed) and site management including IRB/ethics submission, study start up, recruitment, enrolment, document management, database close out, timelines, budgets. Develop any training for sites, investigators* Draft steering committee charters, organize meetings, deliver and memorialize meeting follow up* Organize, execute, memorialize medical advisory board meetings* Work with authors to manage version control, assure manuscripts meet timelines; remain apprised of publications supporting or in competition of product development* Maintain records of media coverage and news* Manage planning and meetings at or with professional societies, drive follow up* Assess feasibility of proposed analyses* Execute surveys and studies to describe patient experience* Join in and help shape R&D strategy; help teams to make medical/ health related decisions that align with business objectives and long-term goalsProfileQualifications/ Knowledge/ Experience* BS in life sciences, and/or masters in clinical research, RPh, or PharmD* Clinical trial experience, multiple studies* Experience working towards GCP and other best practices* Experience writing clinical trial documents* Ability to communicate and connect with stakeholders (health systems, clinical research infrastructure, site investigators, investigative site staff, and patients)* Up-to-date knowledge of the healthcare system, regulatory, regulations, public agencies, decision making processes * Experience communicating and working with clinicians* Experience in developing and implementing medical affair strategies* Experience in applying for and delivering grants, and budgeting/ accountingSkills and Abilities* Presentation skills with attention to details* Communication skills and the ability to deal with a wide range of people. Flexibility and adaptability. Sensitivity to a multicultural environment* Organizational skills - able to work to deadlines and multitask* Project management skills, with a drive for results coupled with the highest medical and ethical standards. Scientific curiosity & Goals oriented* Team player - able to work as part of a multidisciplinary team, support and motivate colleagues* Able to work independently and navigate time zone differences* Able to work proactively and effectively, with creative problem-solving skills* Quantitative and data drivenPersonal Attributes* Interest in healthcare and the consumerisation of healthcare* Willingness to travel both within the United Kingdom and abroad* Flexible attitude towards work and ability to work in a fast-paced environment* Willingness to undertake training, to develop and apply new skills and knowledgeDesirable* Biotech or IVD product launch experience* Experience working within a start up* Experience in healthcare economics analysis, unmet need analysis and designing clinical utility studies for medical technologies* Clinical trial publication experience* Familiarity with EU IVDD/IVDR guidelines and USA FDA pathways* US and European clinician network* PhDJob OfferYou will have a voice and the opportunity to make an impact.Be ready to learn, have fun and be inspired by our passionate, talented team.You will receive equity, a competitive benefits package and annual bonuses. Required skills

Diagnostics

IVD

new product launches

Clinical Trial Manager

working towards GCP

developing medical affairs strategies

Keyskills :
Diagnostics IVD new product launches Clinical Trial Manager wking towards GCP developing medical affairs strategies