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 - To enable 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. Alongside clinical research through our PPD® clinical research portfolio, our work in evidence-based solutions specializes in generating the evidence needed to optimize the commercial potential of our biopharma and biotech customers’ products. Your determination to demonstrate effectiveness, safety and the value of these products will improve health outcomes that people and communities depend on - now and in the future.
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Location/Division Specific Information
The role offers 100% remote flexibility.
#Evidera #Remote
Discover Impactful Work:
The Senior Research Associate (SRA) based in Clinical Outcomes Assessment provides scientific leadership within project teams either independently and/or collaboratively with research scientists, in the conceptualization and execution of COA projects. The SRA participates as an author or internal reviewer of client deliverables, including study protocols, final reports, literature reviews, statistical analysis plans, PRO evidence dossiers, poster presentations, and manuscripts. They also participate in client meetings (face-to-face as well as teleconferences) and provides effective and timely status updates, including identifying issues for escalation. An SRA formulates project work plans, ensures project timelines are met within scope and budget, and are aligned with client expectations. Opportunities to train and mentor junior level staff abound.
A day in the Life:
Science
- Drafts abstracts, posters, oral presentations, and manuscripts
- Conceptually fits individual scientific tasks together to determine how the overall scientific goal will be achieved
- Proficient in methodology around ePRO and translations
- When presented with qualitative data, designs an analysis plan and generates a report fit for client submission
- When reviewing instrument development literature, identifies gaps between the development and the FDA guidance
- Successfully communicates with and advises clients
- Conceptualizes and drafts, or leads, a complete proposal based on a client idea or RFP.
- Demonstrates advanced scientific leadership and direction to project teams
Project Management
- Able to identify staff resources required for efficient teams, present the scope of work, and execute the scope by providing direction and feedback to that team
- Managing internal timelines to ensure that deliverables meet external client timelines
- Managing internal budget/staff hours per project not to exceed contracted budget
- Knowledge of project management systems (electronic and paper filing, SOP requirements, finance office practices, IRB needs, etc)
- Ensures project compliance with paper and electronic filing.
Financial & Business Development
- Leads, reviews, and finalizes project proposals, including budget
- Modifies proposals in response to client requests for changes and scientific insight for client’s strategic needs.
- Independently develops follow-on business with existing clients
Operations Support
- Attends and presents at scientific conferences
- Develops and presents internal scientific trainings
- Participates in staff recruitment efforts (phone screening, interviewing, attending presentations, etc)
- Conforms to SOPs and other Evidera/PPD requirements
- Participate in special assignments (e.g. job descriptions, handbook updates, SOP scientific consulting)
- Supervises mid-level scientific staff
Strategy/Consulting
- Developing client relationships
- Begins to understand pharmaceutical industry and relationship between divisions as they relate to HE/OR groups
- Begins to understand FDA structure and reviewing divisions
- Provides scientifically rigorous deliverables that best helps clients meet their objectives
- Works with PI to help identify scientific methods/plans that help clients meet their goals as well as those that will not help clients meet their goals
- Assists PIs in preparing clients for regulatory meetings
Keys to Success:
Education & Experience
- Doctorate Degree (e.g. PhD; D.Ph.; Pharm D) in science discipline; or
- Master’s degree in science discipline, with at least 5 years’ experience in a relevant field; or
- Bachelor’s degree with at least 7 years’ experience in a relevant field,
Knowledge, Skills, Abilities
- Ability to manage or direct large portfolio of projects in terms of dollar volume and number of projects
- Understanding of health outcomes research principles and familiarity with key aspects of the literature (historical and current)
- Extensive knowledge of practical research implementation (IRB process, data collection and management, knowledge about developing and executing an analysis plan-qualitative and quantitative)
- Knowledge of regulatory guidance documents and scientific guidelines (FDA guidance; FDA qualification documentation; dossier outline; EMA guidance resources; ISPOR Task Force Documents, etc)
- Understanding of instrument development and validation process
- Understanding of relevant qualitative and quantitative methodology
- Demonstrates ability to work well within diverse project teams
- Excellent communication and scientific writing skills, as demonstrated by peer-reviewed publications, technical reports, or other scholarly work
- Strong analytical and problem-solving skills
Benefits
We 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!
Physical Requirements / Work Environment
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
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