Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Preference given to candidates with Pregnancy Registries or Virtual Trial Experience.
Performs and coordinates all aspects of in-house site management on assigned pregnancy registries and surveillance programs in accordance with ICH GCP, FDA guidelines, local regulations, and SOPs. Plays an active role with the team to reach project goals, achieve deliverables, and meet project timelines.
+ Conducts patient and health care provider calls on a regular basis to enroll patients into registries and programs and to collect follow-up data based on various protocols.
+ Performs required communications on a regular basis as described in the protocol, management plan, or other process documents.
+ Provides project status tracking and progress reports to the project lead, as required.
+ Ensures systems such as CTMS and internal trackers are updated based on project conventions and performs regular QC checks.
+ Contributes to the project team by training new team members and mentoring junior team members, assisting in preparation of project tools and sharing ideas with team members, and performing additional projects tasks as assigned by the project lead.
+ Manages essential documents as required by local regulations and ICH GCP before, during, and after the project.
+ May assist project lead or other team members on assigned projects.
**Education**
Bachelor's degree, nursing degree or equivalent and relevant formal academic / vocational qualification.
**Experience**
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
_Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions._
**Knowledge, Skills, Abilities**
+ Ability to work closely with other team members to ensure consistent coverage of all projects during business hours.
+ Ability to evaluate medical research data, proficient knowledge of medical terminology, and ability to utilize problem solving techniques.
+ Effective clinical monitoring skills and demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
+ Excellent understanding of application of FDA guidelines, GCPs, and SOPs.
+ Effective oral and written communication skills with the ability to communicate with medical professionals.
+ Strong customer focus and effective interpersonal skills as well as excellent team player with team building skills.
+ Effective organizational and time management skills as well as strong attention to detail.
+ Proven flexibility and adaptability and ability to work in a team or independently as required.
+ Good computer skills such as Microsoft Office and the ability to learn other software.
+ Good English language and grammar skills as well as good presentation skills.
**Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require travel. (Recruiter will provide more details.)
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 PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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.
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