Manager, Clinical Data Management - Early Development Services(Phase I Clinical Trials) - 149614
The objective of a Manager, Clinical Data Management (CDM) is to manage day-to-day operations for a group of CDM projects or key functions as well as manage the project staff and workloads for direct reports.
A Manager, CDM may be responsible for customer contact, functional, administrative and financial oversight of projects assigned. He/she will participate in the development and implementation of processes, procedures and training for the data management function. The Manager, CDM will provide supervisory functions for individual contributing staff within the CDM department including training and mentoring of staff. Managers may be expected to participate in business development activities.
Education and Experience:
Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)
Minimum of 5 years of data management experience
Acted as a team lead on a multi-person team, not necessarily in data management
Candidates with Phase I EDS experience are highly preferred
Candidates with experience with EDC platforms Rave, Inform, and Trial Master are also preferred
In some cases, a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
Knowledge, Skills and Abilities:
Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global Standard Operating Procedures and client expectations
Strong attention to detail and skill with numbers
Ability to use interactive computer programs
Good written and verbal communication skills
Strong organizational skills
Strong analytical/problem-solving skills
Ability to work productively with minimal supervision
Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
Ability to attain, maintain and apply a strong working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
Strong customer focus and excellent interpersonal skills
Proven flexibility and adaptability
Ability to work in a team environment and independently as needed
Ability to act as a study or department expert for DM processes
Ability to effectively manage and motivate others
Ability to forecast project resourcing and hours needed. Ability to review utilization and make decisions/adjustments as necessary
Ability to supervise and delegate tasks
Must demonstrate good judgment in making decisions
Ability to travel to other locations as required or as business need dictates
Must be able to set and meet, for self and team, timelines or be able to recognize and schedule changes in response to project demands
Strong command of English language and grammar
Manages experienced professionals and / or subordinate management who exercise latitude and
independence in their assignments. Often heads one or more sections or a small department.
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Frequently drives to site locations and frequently travels both domestic and international.
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.
Moderate 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.
Able 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, relates sensitive information to diverse groups both internally & externally.
Ability to apply basic principles to solve conceptual issues.
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.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
Organization - Phase I Data Management
Primary Location - North America-United States-North Carolina-Morrisville - Home Based