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Principal Clinical Data Manager-biotech/pharma (oncology)

THIS IS A REGULAR FULL TIME ROLE THAT INCLUDES FULL BENEFITS PACKAGE, BONUS POTENTIAL AND POSSIBLE STOCK OPTION

THIS ROLE IN ONSITE AT THE CLIENT OFFICES IN EITHER WEST LA OR SOUTH SF

NO REMOTE OR TELECOMMUTE OPTION FOR THIS ROLE

 

Primary Objective of Position

 

Principal Clinical Data Manager, Clinical Data Management, is  responsible for leading study data management activities including, but not limited to, coordination of CRF design, development, review and sign off ; Reviews and approves CRO generated Data Management documents,  coordinates database live and close out activities with the CRO,  provides guidance to CRO to manage query flow and implements quality control plan.  The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed;   may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance

 

Major Duties/Responsibilities

 

Reviews listings to identify data discrepancies and tracks resolutions

 

Works with Study team to design mock CRFs based on the protocol

 

Leads database design, implementation and testing activities

 

Supervises all Data Management deliverables and associated timelines with the CRO to ensure a quality database lock

 

Co-ordinates with Clinical Operations, Biostatistics, Statistical Programming, Safety and other departments, as needed, to resolve data issues

 

Skills & Abilities

 

Excellent organizational skills and ability to prioritize tasks

 

Must be able to work under tight timelines

 

Possess excellent communication skills

 

Anticipates change and reacts quickly and intelligently to accommodate business needs.

 

Physical Demands

 

The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

 

The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit.   May involve travel up to 10%

 

Education & Professional Experience

 

Required:

 

Bachelor’s Degree in a biological sciences or other medically related areas

 

Minimum of 7 years of data management experience in the biotechnology/pharmaceutical industry

 

Familiarity with data management software (e.g. Medidata, Oracle Clinical)

 

Working knowledge of coding dictionaries – MeDDRA and WHODRUG

 

Preferred:

Knowledge of Oncology clinical trials

 

Nursing background

 

Vendor management experience

 

Familiarity with SAS

 

 

 

 

Filed Under: CDM (Clinical Data Manager)

Clinical Data Manager (Oncology)

THIS ROLE IS ONSITE IN EITHER WEST LOS ANGELES OR SOUTH SAN FRANCISCO. NO REMOTE OR TELECOMMUTE. W2 OR CORP TO CORP ONLY

 

Our Biotechnology client has an immediate need for a Clinical Data Manager on a long term contract basis to lead studies in Oncology areas. You will be responsible for coordination of CRF design, development, review and sign off ; Reviews and approves CRO generated Data Management documents, coordinates database live and close out activities with the CRO, provides guidance to CRO to manage query flow and implements quality control plan. The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed; may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance.

 

Responsibilities:

Able to lead a small clinical study or co-lead a larger study or studies with moderate guidance

Able to support several clinical studies with minimal guidance

Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies

Review protocols for appropriate data capture. Able to perform a thoroughly detailed review of data requirements.

Interact with CRAs, programmers, study managers and statisticians.

Develop data edit check specifications and run data listings as

Develop the Data Management Plan for a clinical study.

Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications

Enter data queries into the system to be resolved at investigational sites and manage the resolution of those queries

Perform reconciliation of header data from external data sources against the clinical database

Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines

Assist in database upgrades/migrations including performing User Acceptance Testing

Able to maintain study workbooks and data management files

Perform database lock and freeze activities per company SOPs

Participate in regular team meetings and provide input when appropriate

Provide input into the development of data management SOPs, Work Instructions, and process documents

Assist with the training of new employees and/or contractors

 

Requirements:

BA/BS, preferably in the scientific/healthcare field.

At least 5 years of experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment

Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.

Experience and understanding of the Oncology therapeutic area, and with Phase III pivotal studies are desirable.

Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies.

Filed Under: CDM (Clinical Data Manager)

Sr. Clinical Data Manager (Oncology)

THIS ROLE IS CONTRACT, EITHER W2 OR C2C

NO REMOTE OR TELECOMMUTE. ALL WORK IS ONSITE AT CLIENT’S OFFICES IN EITHER SOUTH SAN FRANCISCO OR WEST LA

Our Biotechnology client has an immediate need for a Clinical Data Manager on a long term contract basis to lead studies in Oncology areas. You will be responsible for coordination of CRF design, development, review and sign off ; Reviews and approves CRO generated Data Management documents, coordinates database live and close out activities with the CRO, provides guidance to CRO to manage query flow and implements quality control plan. The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed; may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance.

Responsibilities:
Able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
Able to support several clinical studies with minimal guidance
Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
Review protocols for appropriate data capture. Able to perform a thoroughly detailed review of data requirements.
Interact with CRAs, programmers, study managers and statisticians.
Develop data edit check specifications and run data listings as
Develop the Data Management Plan for a clinical study.
Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
Enter data queries into the system to be resolved at investigational sites and manage the resolution of those queries
Perform reconciliation of header data from external data sources against the clinical database
Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
Assist in database upgrades/migrations including performing User Acceptance Testing
Able to maintain study workbooks and data management files
Perform database lock and freeze activities per company SOPs
Participate in regular team meetings and provide input when appropriate
Provide input into the development of data management SOPs, Work Instructions, and process documents
Assist with the training of new employees and/or contractors

Requirements:
BA/BS, preferably in the scientific/healthcare field.
At least five – seven years experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
Experience and understanding of the Oncology therapeutic area, and with Phase III pivotal studies are desirable.
Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies.

Filed Under: CDM (Clinical Data Manager)

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