Full Job Description
Summary:
Ensures the contracted Data Management for clinical studies are carried out by the Company in accordance with the executed contract and the customer's expectations. The scope may include projects that are large and/or complex and/or with particular challenge and/or program(s) of trials for same customer. May include line management responsibility.
Essential Functions:
Acts as Project Leader on a stand alone contract ("project") for Data Management, to include:
a. primary customer contact for all contracted Data Management;
b. direct liaison with Finance and Contract department on
required matters (e.g., invoicing, contract changes).
Acts as Functional Lead for Data Management on full service contracts to include:
a. primary contact for internal liaison between Data Management and Company Project Management, Clinical Monitoring, and other functional groups on 'full service' contracts;
b. liaison with Finance and Contracts groups via the Project Leader (e.g., concerning invoicing, contract changes).
Ensures launch, delivery and completion of all Data Management according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
Manages changes of scope, budget, revenue recognition, and participation in monthly internal project reviews.
Monitors and communicates project progress to the customer and project team including use of project status reports and tracking tools/metrics.
Plans, manages, and requests resource as required for assigned studies.
Maintains a consistent, manageable workflow for Data Management project team by monitoring enrollment information and communicating with project team to actively influence data collection.
Develops and maintains:
a. Data Management Plans;
b. Project Management Plans (for stand-alone contracts only);
c. Communication Plans (for stand-alone contracts only);
d. SAE Reconciliation Guidelines;
e. Quality Plans; and other plans as delegated/required.
Assists in the negotiation and contracting process with outside vendors such as e-CRF/Diary vendors, CRF Printer, and IVRS vendors.
Maintains documentation on an ongoing basis and ensures that all filing is up to date.
Regularly reviews project files to ensure that all filing is up to date.
Manages the database freeze and lock processes and procedures.
Ensures that all applicable documents and databases (data sets) are archived or returned to the customer appropriately.
Coordinates user testing per User Test Plans developed for data entry screens, electronic edit checks, data listings, import/export programs, and medical coding.
Provides project specific training for:
a. CRAs to be able to train site staff to use EDC system;
b. site staff to use EDC system;
c. project team in project specific requirements.
Manages Quality Control (QC) process for checks of CRF database versus Case Report Forms (CRFs) and Data Clarification Forms (DCFs):
a. specifies required CRF database listings;
b. summarizes results and resolves issues from checks of such listings against CRFs and DCFs.
Schedules and requests data transfers/imports/exports to/from CRF/eCRF database and associated databases.
Reviews and approves:
a. project plans and guidelines for data validation, electronic data interchange, coding, CRF/eCRF screen, database design, user testing, CRF tracking, CRF/eCRF completion and other applicable project plans as delegated/required;
b. specifications for listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources;
c. output from listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources.
Participates in, and presents at internal, customer, third-party, and investigator meetings.
Plans for and creates necessary documentation to support internal and external audits; participates in such audits.
Participates in the development of departmental technologies, SOPs, processes, and procedures.
Develops and delivers applicable data management departmental training.
Trains and mentors data management staff.
Contributes to the Request for Proposal (RFP) and Request for Information (RFI) process. Prepares input for, and participates in proposal bid defense meetings.
Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business. May represent the Company at professional meetings or seminars.
Line management responsibilities for all assigned direct reports, including professional development/training, performance appraisals, employee counseling, performance management issues, interviewing, and selection; assignment of project work; and workload reviews. Establishes goals for direct reports that will increase knowledge and skill levels, and delegates tasks commensurate with skill level. Works with and advises direct reports on administrative policies and procedures, technical problems, priorities, and methods.
Other Responsibilities:
Performs other work related duties as assigned. Minimal travel may be required (up to 25%).
Requirements:
BA/BS in the biological sciences or related disciplines in the natural science/health care field. Moderate clinical data management experience or an equivalent combination of education and experience. Experience Clinical Data Management practices and relational database management software systems. Demonstrated staff leadership skills. Contract Research Organization (CRO) experience preferred. Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. Effective oral and written communication skills. Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
