Military Spouse Connection Jobs

Work Schedule

Standard (Mon-Fri)

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.

We have an exciting opportunity to join our best-in-class Digital & Decentralized Solutions department. PPD pioneers digital capabilities and deploys solutions to streamline protocols, putting patient experience at the center of every design. We offer services in Telemedicine, Direct to/from Patient models, Remote eConsent, Home Health Care & Nursing, eCOA and ePRO solutions, Mobile sites, Remote Monitoring and Device & Wearables.

The Digital Implementation Manager is responsible for the technical and operational aspects of the electronic clinical outcomes assessments (eCOA) and digital enablement (DE) projects, to achieve the successful completion of eClinical software builds for our clients. Provides support to the team with both study related tasks, internal operational tasks, and digital implementation management of single scoped studies.

Essential Functions:

• Supports digital implementation projects

• Manages internal resources, translation vendors, and instrument copyright

holders (manage contract tasks as needed). May own one or more of these

relationships at the department level.

• Performs eTMF filing.

• Coordinates project training needs as directed.

• Maintains project documents as directed (i.e. meeting minutes).

• Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.

• Executes periodic quality reviews as directed.

• Initiates and prepares, reviews and finalizes all project/program plans required

by government/client contracts by reviewing contract and communicating with

functional area leads.

• Coordinates project/program/protocol specific and therapeutic area training

needs. Tracks and follows up on all training, non-disclosure agreements, and

security clearance requests as required.

• Schedules, leads and follows up on pre-identified meetings. May be internal

and/or external.

• Ensures compliance to established project-specific parameters, authority

approval, and client expectations.

• Identifies and assesses legal, financial and operational risks in accordance with company and client considerations and escalates to appropriate level of the organization per established processes.

• Performs intermediate project financial management tasks as assigned.

• Provides training and guidance to junior team members.

• Assists in internal process and improvement initiatives.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to

2+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Working knowledge of Digital Solutions and their relevance in clinical research

• Basic knowledge of Project Management for digital solutions

• Basic understanding of the translation and linguistic validation process

• Able to manage external vendors according to project scope, budget, timelines and quality standards

• Displays effective communication skills (listening, oral, written) and can communicate in English language (oral, written)

• Sound interpersonal skills, is flexible and adapts to changing situations

• Ability to persuade, convince, and influence or impress others

• Organized, proficient at multi-tasking with good attention to detail

• Able to coordinate tasks and teams

• Ability to effectively use automated systems and computerized applications such as Outlook, Excel,

Word, etc.

• Possesses cross cultural awareness and is able to adapt appropriately

• Has an understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology

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.