Job Listing: Clinical Data Manager

A Worldwide Clinical Research Organization is searching for a Clinical Data Manager based out of their Research Triangle Park office in Raleigh-Durham, NC. Candidates considered should have the below qualifications for this position.

Essential Function
The CDM III’s essential function is to independently organize and manage all clinical data management activities on projects (commensurate to their job role). Responsible for coordinating a moderate to large team or multiple small size protocols as the Primary CDM, with minimal to no supervision. Alternatively, take on role of DM Lead on smaller projects. Ability to solve problems using logical and systematic approaches is critical. Must thoroughly understand the various tasks relating to project initiation, ongoing processing and lock, or be a dedicated member of staff in a specific area of data management. Must have solid understanding of therapeutic indications and study hypothesis. Work to the appropriate standards of quality and efficiency.

Relationships
Reports T- Associate Manager, Manager or Senior Manager, Data Management Operations
Directly Supervises Not applicable
Provides Work Direction t- Project team members as appropriate
Works Closely with All project team members
External Relationships Sponsor counterparts and teams, investigators, third party vendors, auditors and regulators

Key Accountabilities
- Assume the ability to meet the requirements of a CDM I and II with a high degree of proficiency and autonomy
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to others in an open, balanced and objective manner
- Act as an independent Primary CDM on complex or multiple projects, DM Lead on smaller projects or coordinate a team in a specific area of DM.
- Initiate and maintain high quality DM study file documentation
- Provide input to protocol review
- Manage all phases of data management activities from study start up to database close
- Direct team members in daily activities
- Define and monitors metrics and modifies plan accordingly
- Mentor project team members
- Facilitate cross functional team meetings both internally and externally
- Actively review and provide feedback of study contract / BESTT and study productivity
- Recognize out of scope activities and communicates to PM / DM Lead
- Represent Data Management in external client meetings and presentations such as investigator meetings and bid defenses. May represent company at professional Data Management meetings / conferences
- Keeps manager(s) informed about work progress and any issues to avoid surprises. Requires minimal supervision by Manager
- Apply knowledge across multiple projects
- Define study specific processes
- Identify inconsistencies and inefficiencies in processes and recommends solutions
- Coordinate a moderate to large team or multiple small size protocols.

Skills
- Excellent interpersonal, verbal and written communication skills
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Willingness to work in a matrix environment and to value the importance of teamwork
- Carefully weighs the priority of project tasks and directs team accordingly
- Understands the strengths and development areas of team members
- Gives others appropriate latitude to make decisions
- Looks for win-win solutions to solve problems
- Ability to make appropriate decisions in ambiguous situations
- Ability to solve problems by using a logical, systematic, sequential approach
- Communicate and work effectively with clients
- Enlists the support of team members in meetings goals
- Proposes new approaches, methods or technologies
- Anticipates how others will react to situations
- Plans and delivers verbal and written communications that persuade the intended audience
- Demonstrate a sound awareness of all relevant regulations, including GCP
- Demonstrate a sound awareness of internal CBOPs, CPs, Corporate Quality Manual, WSOPs and Operational Guidelines
- Willing and able to travel as required – local or international



Education
- Bachelor’s degree and / or other medical qualification or relevant DM experience.

Language Skills
- Excellent English written and oral communication skills.

Minimum Work Experience
- Previous data management experience preferred, or clinical and / or research experience with solid understanding of clinical trials methodology and terminology.



NO RELOCATION ASSISTANCE AVAILABLE FOR THIS POSITION

Required Skills for Clinical Data Manager Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.