Documentation Services Manager

Title: Documentation Services Manager (WORD version ) (Customer diagram)

Industry: Pharmaceutical

Function: Customer Support

Value-Added Results/Weights Performance Standards

Clinical development (40%)
• CRF development
• CRF development work is signed off and approved forms are ready for production within established time frames.

• CRF production • Completed CRFs are delivered to Clinical Development on time.

• CRF Inventory/Monitoring • CRF inventory is available prior to clinical first monitoring visit.

• Resource schedules and tracking spreadsheets • Spreadsheet is maintained with the most current status information and can be accessed by management staff of Clinical and Biometrics.

• Management reporting • Weekly enrollment reporting, workload status and subject status by study are completed by Friday noon.
• Ad hoc projections are completed by agreed-upon deadlines.

• Master forms • Clinical and Biometrics are aware of and use standard formats.

• Task force participation • Manager is satisfied that processes are clarified, efficiencies are introduced and responsibilities and accountabilities are specified as a result of the task force meetings.

QA Doc/Regulatory/ Biometrics Management (20%)
• SOP for Biometrics

• SOP for corporation
• Standard Operating Procedures (SOPs) are completed and approved.
• SOPs requiring Biometrics approval are reviewed by agreed-upon deadlines.

Biometrics Management (20%)
• Administrative
• Requested work is completed by agreed-upon deadlines.

• Budget • VP is satisfied with overall budget status information, budget status information by category, and projected budget needs.

• Space and equipment • VP is satisfied that the space and equipment are adequate for Biometrics permanent and temporary employees.

• Management • VP is satisfied that the department policies, job descriptions and staff development plans are up-to-date and reflect department needs.

• Presentation materials • Presentation materials meet agreed-upon needs of the presenter.

External clients (10%)
• Print service vendors
• Printing vendors deliver quality product in a timely fashion for a competitive price.

• CROs • Contract amendments are approved in a timely fashion, billing is verified, and invoices are paid in a timely fashion.

• New technology • Technologies and working standards reflect the use of appropriate and new technologies.

Doc. Services Group Output (10%)
• Developed and produced CRFs

• Trained and productive Document Services staff

• Balanced and reasonable Document Services workload
• CRFs are produced in a timely and efficient manner.
• VP is satisfied that the workload is being met and the employees have been trained and prepared for the work they are assigned.

• The employees agree that workload is balanced and reasonable.

Customer Diagram: Documentation Services Manager

Value-Added Results/Weights	Performance Standards
Clinical development (40%) • CRF development	• CRF development work is signed off and approved forms are ready for production within established time frames.
• CRF production	• Completed CRFs are delivered to Clinical Development on time.
• CRF Inventory/Monitoring	• CRF inventory is available prior to clinical first monitoring visit.
• Resource schedules and tracking spreadsheets	• Spreadsheet is maintained with the most current status information and can be accessed by management staff of Clinical and Biometrics.
• Management reporting	• Weekly enrollment reporting, workload status and subject status by study are completed by Friday noon. • Ad hoc projections are completed by agreed-upon deadlines.
• Master forms	• Clinical and Biometrics are aware of and use standard formats.
• Task force participation	• Manager is satisfied that processes are clarified, efficiencies are introduced and responsibilities and accountabilities are specified as a result of the task force meetings.
QA Doc/Regulatory/ Biometrics Management (20%) • SOP for Biometrics • SOP for corporation	• Standard Operating Procedures (SOPs) are completed and approved. • SOPs requiring Biometrics approval are reviewed by agreed-upon deadlines.
Biometrics Management (20%) • Administrative	• Requested work is completed by agreed-upon deadlines.
• Budget	• VP is satisfied with overall budget status information, budget status information by category, and projected budget needs.
• Space and equipment	• VP is satisfied that the space and equipment are adequate for Biometrics permanent and temporary employees.
• Management	• VP is satisfied that the department policies, job descriptions and staff development plans are up-to-date and reflect department needs.
• Presentation materials	• Presentation materials meet agreed-upon needs of the presenter.
External clients (10%) • Print service vendors	• Printing vendors deliver quality product in a timely fashion for a competitive price.
• CROs	• Contract amendments are approved in a timely fashion, billing is verified, and invoices are paid in a timely fashion.
• New technology	• Technologies and working standards reflect the use of appropriate and new technologies.
Doc. Services Group Output (10%) • Developed and produced CRFs • Trained and productive Document Services staff • Balanced and reasonable Document Services workload	• CRFs are produced in a timely and efficient manner. • VP is satisfied that the workload is being met and the employees have been trained and prepared for the work they are assigned. • The employees agree that workload is balanced and reasonable.