Work Schedule

Other

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.\n\nLocation/Division Specific Information\nOur global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.\n\nDiscover Impactful Work:\nManages the day to day activities, performance and supervision of the research site. Responsible for the effective execution of site protocols and providing daily direction to the site’s staff. Acts as the liaison between the investigator and the research team and ensures the execution and coordination of clinical research activities according to the organization’s SOPs, ICH/GCP and FDA guidelines.\n\nA day in the Life:\nUnder direction of principal investigator, provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site.\nProjects staffing requirements and liaises with operations on staffing needs and flow of clinical procedures for upcoming studies.\nMay serve as project manager and/or study coordinator on a given protocol, as appropriate.\nEvaluates new operational strategies to enhance efficiencies, provide competitive advantages, and improve overall profitability of the site.\nEvaluates potential study opportunities and facilitates the feasibility process, considering both recruitment and operational concerns.\nEstablishes rapport with the local healthcare community to increase awareness of site operations, foster relationships with local physicians, and develop additional subject and patient recruitment solutions.\nManages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime\nKeys to Success:\nEducation\nBachelor's degree or equivalent and relevant formal academic / vocational qualification\n\nExperience\nPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).\n\n1+ year of leadership responsibility\nIn some cases an equivalency, consisting of a combination of appropriate education, training\n\nand/or directly related experience, will be considered sufficient for an individual to meet the\n\nrequirements of the role.\n\nKnowledge, Skills, Abilities\nAdvanced knowledge of clinical trial processes and expertise / knowledge of clinical study operations\nKnowledge of FDA regulations and ICH GCP guidelines\nKnowledge of budgeting / forecasting / planning projects\nStrong management and proven leadership skills\nExcellent time management skills and ability to work on multiple projects simultaneously\nProblem solving and troubleshooting abilities\nExcellent written and verbal communication skills\nProficient in Microsoft Office products\nCapable of acting as a liaison with the client, investigator, study team and other departments/divisions\nPhysical Requirements / Work Environment\nWork is performed in an office and/or a clinical environment with exposure to electrical office equipment.\nExposure to biological fluids with potential exposure to infectious organisms.\nOccasional drives to site locations, frequent domestic travel and rare international travel.\nPersonal protective equipment required such as protective eyewear, garments and gloves.\nExposure to fluctuating and/or extreme temperatures on rare occasions.\nFrequently vertical and /or stationary for 6-8 hours per day.\nRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.\nFrequent mobility required.\nFrequent bending and twisting of upper body and neck.\nLight to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.\nAbility to access and use a variety of computer software developed both in-house and off-the-shelf.\nAbility to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.\nFrequently interacts with others, relates sensitive information to diverse groups.\nAbility to apply basic principles to solve conceptual issues.\nPerforms a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.\nRegular and consistent attendance.\nBenefits\nWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!