Data Lifecycle Manager

This position will work primarily in supporting the Study Services group and will be responsible for developing and delivering quality study management and technical input to the Study Services and Technology & Communications’ Teams.  In addition, this position will manage all aspects of clinical data management for designated studies, including case report form design, data tracking and entry, data cleaning, coding, document processing and study close-out activities.  This position will also provide study coordination to PharmaPros’ partners and clients as needed.  This position will report directly to the Director of Data Services.

 

Principal Responsibilities (other duties may be assigned):

 

· Provide leadership and study management support to all data services operations, projects and personnel. This includes developing and managing projects, establishing priorities and maintaining deadlines.

· Work with the Director of Compliance, Data Services and Technology to manage study timelines and resource allocation activities within project scope and budget.

· Serve as primary liaison to assigned clients for all data management needs.

· Initiate customer contact and hold customer meetings as needed.

· Manage all aspects of the project kick-off meeting for designated clients, including the creation and maintenance of study documentation.

· Manage all aspects of clinical study start-up and data processing, including training, requirements gathering, CRF design, data tracking, entry, cleaning and coding; Manage the coordination of this work with Technical Team, Data Management organization and other vendors/partners.

· Oversee database closure activities for interim or final data analyses.

· Work with the Technical Services Team to provide technical input when applicable and ensure that technical study projects are completed within defined project scope and budget. 

· Confer with project personnel to provide expertise and advise as needed.


General Responsibilities:

 Assist in the development and maintenance of SOPs/Guidelines. Assist in audit preparation and delivery. Ensure company and departmental SOPs, procedures and policies are followed.  Provide project management and leadership in coordinating e-data lifecycle services projects with potential and obtained clients.  This may include, but is not limited to, presenting on PharmaPros’ eDLM Services at client meetings, conferences, investigator/sponsor meetings, etc. Assist in the preparation of e-DLM Services proposals for potential clients. Assist with other e-DLMs Services and other PharmaPros business areas responsibilities as requested.

 

Computer Skills:  Clintrial 4, SQL, SAS, MS Word, MS Excel, MS Project, and PageMaker (or an equivalent forms design tool).



 

Travel requirements:  Approximately 25% average per year.

 

Education/Experience:

 

This position requires a BS/BA and/or 4-8 years of relevant data management, technical and Industry experience with at least 2-3 years of previous supervisory management experience.  This position also requires:

 Knowledge of FDA regulatory requirements Knowledge of Good Clinical Practices (GCPs)  Successful management of multiple projects and resources Experience managing CRO’s, Central Labs, etc. Experience managing studies using EDC, IVRS and/or ePRO technologies Experience gathering eCRF requirements from study protocols Ability to write advanced SQL queries / program in SAS Ability to function as an effective leader in a team environment Expert knowledge of data management concepts Proven managerial and leadership skills for professionals Well-developed problem-solving and decision-making skills Ability to communicate clearly and effectively (both written and oral communication) The ability to work in a remote team environment A highly organized self-starter with excellent interpersonal skills, leadership, communication and organizational skills