Profil Institute for Clinical Research, Inc.
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Clinical Data Manager
at Profil Institute for Clinical Research, Inc.
Summary: The Clinical Data Manager (CDM), under the direction of the Director, Clinical Data Management, is responsible for the daily clinical data management operations of studies managed by ProSciento. The Clinical Data Manager will concentrate on good data management documentation practices and apply ProSciento procedures to provide excellent service to our sponsors. Higher level CDMs will also mentor lower level staff. Performs duties in accordance with company’s values, policies, and procedures.
Please Note : ProSciento is looking to hire a Senior Clinical Data Manager for this opening.
Essential Duties and Responsibilities will include the following. Other duties may be assigned at the company’s sole discretion.
- Leads the process of Electronic Case Report Form (eCRF) development for a study. Designs and tests studies in ProSciento’s data management system.
- Manages workload for 3 to 4 single-site and/or full scope CRO trials, or a combination of single or multiple site CRO projects.
- Leads the development and maintenance of the Data Management Plan (DMP).
- Creates study-specific data entry instructions and conventions.
- Creates and maintains the data validation specifications.
- Designs edit checks within the ProSciento data management system that conform to the data validation specifications.
- Performs discrepancy management within the ProSciento data management system.
- Routinely reviews data issues with internal site staff and assists Data Entry Associates with updates according to discrepancy responses to maintain a clean database.
- Develops data listings and reports from the data management system and performs trend analysis to inform data review, using tools such as Smart Reports in the EDC.
- Creates and maintains study status reports for tracking eCRF completion, discrepancy management, and other study metrics as needed.
- Performs medical coding of adverse events and concomitant medications.
- Manages and QCs data received from external vendors.
- Prepares and QCs internally generated data for review by CRAs or the project manager, and for transfer to clients.
- Supports the Director, Clinical Data Management, in the oversight of CROs or third-party vendors for any outsourced studies.
- Attends team meetings as needed to represent CDM interests.
- Reviews protocols and provides input relevant to data management issues.
- Provides input for the development of project specific timelines and budgets.
- Trains on department specific Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Additional Duties and Responsibilities for Senior Clinical Data Manager
All duties defined in level one, and in addition:
- Manages workload for 3 to 4 full scope CRO trials, including multi-site projects, or a combination of single or multiple site CRO projects.
- As directed, oversees the projects of other CDMs and mentors as needed.
- Develops and maintains CDM procedures, standards, and practices.
- Oversees third party vendors for any outsourced studies, including biostatistics vendors, and assists in relationship management.
- Assists in creating budget estimates for potential studies and providing proposal input to Budgeting and Contracting.
- Assists department head in resource and project planning.
- Assists department head with overall key performance indicators and metrics analyses.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
CDM Education and Experience:
Bachelor’s degree in life sciences or mathematics and/or formal or on-the-job training in clinical trial methodology and Good Clinical Practice (GCP) plus three or more years of experience in direct data management experience at a CRO, pharmaceutical, or biotechnology company and/or an equivalent combination of education and experience. Experience writing data entry and training documentation.
Senior CDM Education and Experience:
Bachelor’s degree in life sciences or mathematics and/or formal or on-the-job training in clinical trial methodology and Good Clinical Practice (GCP) plus five or more years of experience in direct data management experience at a CRO and obtained Certified Clinical Data Manager (CCDM) status, or seven or more years of experience without CCDM. Experience writing SOPs and training documentation and mentoring data management staff. Experience using visual analytics and business intelligence tools for performance monitoring. Experience with randomization and inventory systems (e.g., IWRS) to lead technical oversight. Demonstrated use of project management tools and skillsets.
Skills, Knowledge, and Abilities:
Technical competency using data management systems, especially EDC systems. Understanding of US and international regulatory mandates and guidance for clinical research including FDA/ICH-GCP. Demonstrated ability to manage a complex workload and prioritize tasks based on program goals. Ability to work quickly and independently and as a strong team player.
Certificates and Licenses:
Certificate in building EDC systems preferred. CCDM strongly preferred at Senior CDM level and above.
Ability to read and interpret documents such as SOP’s, WI’s, procedural manuals, governmental and clinical regulations, and similar documents. Excellent oral, written and interpersonal communication skills with the ability to communicate effectively to employees and Management groups and in group meeting settings.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Computer Skills: To perform this job successfully, an individual should have intermediate knowledge of the current MS Office Suite.
The work environment characteristics described here are representative of those an employee may encounter while performing the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet to moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close, distance and peripheral vision as well as depth perception and the ability to adjust focus. While performing the duties of this job the employee is regularly required to sit, talk and hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk, stoop, kneel, crouch, or crawl.