Project Assistant

Work Schedule

Environmental Conditions

Job Description

As part of our PPD clinical research team youll have the opportunity to support groundbreaking studies that make a real difference in patients lives.

Position Summary
As Project Assistant you will provide administrative and technical support to Project Team including planning organizing and coordinating responsibilities of project administration. You will maintain procedures guidelines and documentation maintain project records and ensure that all regulatory documents are correct processed and approved. You will be responsible for completing data entry and maintenance of data base repositories. The Project Assist also supports with preparing reports and data collection for analysis.


Position Requirements
Assists with review coordination and compilation of files and other materials.
Distributes project documents and supplies.
Processes and tracks local regulatory study specific or department documents.
Performs file review. Organizes and maintains correspondence files and other departmental records. Analyzes and reconciles project documents metrics and findings reports within specified timelines.
Assists with clarification and resolution of findings related to documentation.
May assist with translation materials and translation QC upon request.
Composes copies and distributes communications reports documents and forms. Performs mass mailings and communications.
Maintains vendor trackers.
Provides accesses to company client and vendor systems.
Processes local payments (translations EC/IEC other local vendors etc.)
Assists on project management ad-hoc activities producing reports or on study plan edition.
Coordinates team conference calls and completes and distributes meeting minutes from internal/client/vendor meetings as applicable.
Maintains a working knowledge of applicable GCPs organization and client SOPs and/or protocol-related specifics through professional career development to ensure continued compliance.
Serves as a resource to the project team.

Education and Experience Requirements

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to at least 2 years).

Required Knowledge Skills and Abilities:
Self-motivated positive attitude with effective oral and written communication and interpersonal skills
Ability to work in a team or independently as required
Good organizational skills and strong attention to detail with demonstrated ability to handle multiple tasks efficiently and effectively
Ability to effectively analyze and update project-specific data/systems to ensure accuracy and efficiency
Strong flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
Strong customer focus
Ability to attain and maintain a good working knowledge of applicable regulations and procedural documents for all non-clinical/clinical aspects of project implementation execution and closeout
Good English language and grammar skills
Good computer skills proficient in MS Office ability to obtain knowledge and master all database systems and modern technology
Good critical thinking skills including but not limited to critical mindset in-depth investigation for appropriate root cause analysis and problem solving
Skills to work under constant pressure to meet project/client deliverables and timelines
Ability to successfully complete required training program(s) as applicable

Working 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:

Work is performed in an office or clinical environment with exposure to electrical office equipment
Occasional drives to site locations. Potential occasional travel required
Frequently stationary for 4-6 hours per day
Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists
Occasional mobility required
Occasional crouching stooping bending and twisting of upper body and neck
Occasional light lifting and/or carrying of objects with a maximum lift of 5-15 lbs. (2-6 kgs.)
Ability to access and use a variety of computer software developed both in-house and off-the-shelf
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
May interact with others relating and gathering sensitive information. Interaction includes diverse groups
Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration
Performs 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
Regular and consistent attendance