Project Specialist II

Summarized Purpose:

Leads contract compliance activities to support the coordination and management of clinical trials projects and/or programs during all aspects of operations.

Essential Functions: Initiates, 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. Provides recommendations and alternative resolutions to project-specific challenges through established escalation channels. Performs intermediate project financial management tasks as assigned. Acts as task order/work assignment lead on small scopes of work for contracts/projects of low-moderate complexity. Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate. Provides training and guidance to junior team members. Executes periodic quality reviews and peer feedback and completes required reports.

Summarized Purpose:

Leads contract compliance activities to support the coordination and management of clinical trials projects and/or programs during all aspects of operations.

Essential Functions: Initiates, 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. Provides recommendations and alternative resolutions to project-specific challenges through established escalation channels. Performs intermediate project financial management tasks as assigned. Acts as task order/work assignment lead on small scopes of work for contracts/projects of low-moderate complexity. Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate. Provides training and guidance to junior team members. Executes periodic quality reviews and peer feedback and completes required reports.

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 5 years). Management Role: No management responsibility Working Conditions and Environment: Exposure to high pressure, intense concentration needed Must pay constant attention to detail-visual, mental Must be able to multi-task constantly Frequent interaction with clients / associates required Long, varied hours required occasionally Travel and rotating shifts required on rare occasions

Exposure to toxic materials on rare occasions Physical Requirements: Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. 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. Frequently interacts with others to obtain or relate information to diverse groups. 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.

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 5 years). Management Role: No management responsibility Working Conditions and Environment: Exposure to high pressure, intense concentration needed Must pay constant attention to detail-visual, mental Must be able to multi-task constantly Frequent interaction with clients / associates required Long, varied hours required occasionally Travel and rotating shifts required on rare occasions

Exposure to toxic materials on rare occasions Physical Requirements: Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. 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. Frequently interacts with others to obtain or relate information to diverse groups. 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.