FSP Digital Implementation Manager

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Summarized Purpose:

Provides support to the team with both study related tasks, internal operational tasks, and digital
implementation management of single scoped studies.

Essential Functions and Other Job Information:

• Supports digital implementation projects in both support of senior team
members and in a digital implementation manager capacity.
• 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.
Works on problems of moderate scope where analysis of situations or data requires

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