Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Summarized Purpose:
Acts as a study manager for multiple studies individually or as a program of several studies. May perform the Project Manager role for standalone studies. Responsible for functional administrative and financial oversight of assigned projects.
Essential Functions and Other Job Information:
Essential
Provides support and coaching to the DM team to ensure that all tasks are
Functions completed accurately on time and within budget to meet or exceed client
expectations.
Acts as a primary liaison for project team and client.
May develop and implement study specific training for DM project staff and
performs independent reviews of DM deliverables following CDM guidelines.
Monitors evaluates and proposes mitigation strategies surrounding risk to
deliverables and finances. Participates in business development activities by
assisting with bid preparation and representing data management at bid defense
meetings where required. Additionally promotes repeat business by developing
relationships with new and existing clients.
Performs project forecasting of hours and identification of resource requirements
and manages project budgets including identification of out of scope work and
participate in the Contract Modification process.
Participates in the development and implementation of processes procedures
and training for the data management function as directed.
Mentors junior level staff and peers on all associated tasks within a study or
program.
Independently leads and delegates tasks to ensure timely completion of project activities to project timelines quality and budget.
Job Complexity Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Job Knowledge Having wide-ranging experience uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry
exist at this level (e.g. dept. / peer review). Level at which career may plateau.
Supervision Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e. Team Lead). Exercises judgment in selecting
methods techniques and evaluation criteria for obtaining results.
Received
Business Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of
projects or contracts. Creates formal networks with key contacts outside own area
of expertise.
Qualifications:
Education and Experience:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 8 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 global SOPs and client expectations
Ability to use interactive computer programs
Excellent written/ verbal communication skills with a strong command of English language and
grammar; strong organizational and analytical/problem solving skills; strong customer focus and excellent interpersonal skills
Ability to identify project risks and to effectively evaluate and develop plans to mitigate those risks
Ability to maintain a high degree of confidentiality with clinical data and clients proprietary data
Ability to act as a study or department expert for DM processes.
Ability to train and direct a study team providing leadership and direction to both subordinates and
peers
Ability to forecast project resourcing project timeline planning and adherence to timelines.
Ability to supervise and delegate tasks.
Ability to successfully apply above skills knowledge and abilities across a portfolio of studies
Management Role:
No management responsibility
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.
Required Experience:
IC
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