Clinical Data Team Lead

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:

Acts as the lead data manager for one or more projects or to provide support to the lead data manager.

May lead all data management activities for individual, limited volume/complexity studies with support from senior team members. Acts as an interdepartmental and client liaison for all DM study activities.

Essential Functions and Other Job Information:

Essential  Functions

 Applies relevant components of the project protocol to daily tasks and directs

others on how to apply to their daily tasks.

 Acts as a liaison to the Project Lead and/or client as required and communicates

with management regarding all data management (DM) activities within their

studies.

 Develops and maintains data management project documentation files; performs

independent reviews of data management deliverables following documented

CDM guidelines.

 Develops and delivers study specific training for DM project staff.

 Produces project-specific status reports for management, Project Lead and/or

clients on a regular basis. Monitors study metrics.

 May participate in business development activities by assisting with bid

preparation and/or representing data management at bid defense meetings,

where required.

 Assists with project forecasting of hours and identification of resource

requirements and identifies potential out of scope activities to Project Lead and

management and assists with the Contract Modification process.

 Mentors junior level staff on all associated tasks within a study.

 Assists with the administrative and financial management of allocated projects.

Performs all assigned data management activities independently and efficiently,

with attention to quality.

Job Complexity

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

Job Knowledge

Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

Supervision Received

Normally receives general instructions on routine work, detailed instructions on new

projects or assignments. Exercises judgment within defined procedures and

practices to determine appropriate action.

Business Relationships

Contacts are primarily internal to the company with infrequent external customer /

vendor contact on routine matters. Builds productive internal / external working

relationships.

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:

 Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to

regulatory guidelines, SOPs and client expectations

 Ability to use interactive computer programs

 Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail

 Ability to work productively with minimal supervision

 Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data

 Strong customer focus and excellent interpersonal skills

 Proven flexibility and adaptability

 Ability to work in a team environment and independently as needed

 Ability to train and direct study team

 Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands

Working Conditions and Environment:

 Work is performed in an office environment with exposure to electrical office equipment.

 Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

 Frequently stationary 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, 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.

 Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple 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.