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Clinical Contracts Associate - III

Ascent

Job Description

Job Title: Development Business Operations Senior Associate
Industry: Pharma/Biotechnology
Location: Foster City, CA
 
General Position Summary / Purpose:

The Development Business Operations Senior Associate in the Document Management Team (DMT) will collaborate with Development Business Operations leadership, Clinical Records, Clinical Operations Teams, and Development Business Operations functional groups in the planning, development, and implementation of standards, processes, and projects for DMT designed to ensure the effective and efficient archiving of clinical agreements and related information created in support of clinical research. Comply with relevant regulatory, legal, country specific and corporate requirements to produce and maintain inspection readiness for clinical records.

Key Accountabilities / Core Job Responsibilities

• Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements
• Collaborate with Development Business Operations leadership, Development Business Operations functional groups, clinical operations teams, and functional areas outside of Development Business Operations to ensure compliance with policies, procedures, and the practices of records management/TMF archival initiative
• Work with management and DMT personnel in the development, implementation and maintenance of classification and filing systems to meet administrative, research, regulatory, legal, and financial requirements (e.g. filing of agreements in legal archive, Apttus, and eTMF GDAR system)
• Work with management to manage business continuity procedures, including management of paper agreements
• Perform central intake activities including creating records of incoming documents within the first business day of receipt, filing of incoming documents, and retrieve copies of paper protocol agreements from TMF room for Apttus filing
• Responsible for ensuring the central intake report is generated daily and published in a timely fashion
• Evaluate regulatory and business recordkeeping, archiving requirements, and organizational objectives and ensure Development Business Operations DMT is aligned with all
• Responsible for the continued maintenance of eTMF (GDAR) and Apttus contract filing
• File incoming documents and retrieve copy of paper protocol agreements from TMF room for Apttus filing
• Ensure record filing is kept up to date is performed accurately by DMT members
• Develop and maintain quality assurance and control plans
• Responsible for monitoring accuracy of the team’s work by providing reports and metrics to the management team
• Responsible for leading assigned meetings/projects and will mentor/help more junior staff with complex initiatives
• Develop and maintain department process guidance, training materials, policies and procedures, and other quality documents
• Define and manage processes associated with the storing, archiving, indexing, scanning, and classifying clinical records
• Manage the off-site storage of records for Development Business Operations agreements and collaborate closely with Clinical Records team to ensure proper process is in place for off-site archival of paper agreements
• Collaborate and partner with the Information Technology (IT) GDAR Team, through stellar communication and solid project management. Resolve efficiently any issues encountered by collaborating with IT in the improvement of processes, procedures, and effective use of available information technologies
• Operate as the Subject Matter Expert (SME) in the electronic TMF (eTMF)
• Respond to internal and/or external information inquiries related to contract filing and records retention of those agreements; supports internal and external audits and inspections, including provision of data on contract filing
• Manage the DMT mailbox by responding to daily email inquiries, review of incoming agreements for technical review and 30 day contemporaneous filing in eTMF (GDAR) and Apttus
• Participate in the development, implementation and maintenance of internal systems and processes used to manage collections of agreements and filing of documents to GDAR and Apttus
• Track and maintain departmental metrics related to operational activities, progress of contract filing and archive, quality measurements and other variables. Develops appropriate tool sets for capturing metrics and generating reports.
• Responsible for the day-day activities associated with the quality check of clinical agreements and management of contract filing and archival
• Ensure appropriate documentation completed to track archival of files
• Support Development Business Operations Functional Teams and Clinical Operations Study Teams in understanding TMF-related responsibilities, requirements and expectations
• Manage Development Business Operations TMF protocol list for legacy and active protocols and Development Business Operations TMF Comprehensive Review Trackers and Agreements Missing in TMF
• Provide management with DMT TMF metrics; completeness and quality of TMF documentation and content, including the percent completeness and risk level of outstanding items on a periodic and/or adhoc basis as requested by management
Qualifications / Requirements
• 5 plus years of project or clinical trial management experience
• 5 plus years of project leadership experience with PMP preferred
• 3 - 5 years in management position responsible for the establishment and maintenance of procedural documents
• 3 plus years of Clinical Research Associate (CRA) or relevant records management/ TMF management experience equivalent experience preferred
• Exemplary interpersonal skills with proven demonstration
• Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management
• Expert in Microsoft programs including, but not limited to, MSWord, PowerPoint, Visio, Access, and Excel
• BA/BS required
• The Sr. Associate needs subject matter expertise in Trial Master File (TMF) Quality and Records Management.
• The Sr. Associate has foundational skills in Influencing and Leadership, and demonstrates advanced Teamwork skills. Must have foundational abilities in all TMF and contract filing technical competencies, including Quality Management and Change Management.

Job Requirements

 
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Job Snapshot

Location US-CA-Foster City
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Clinical & Scientific

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Terms & Conditions
Snapshot
Ascent
Company:
US-CA-Foster City
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Clinical & Scientific
Store Type:

Job Description

Job Title: Development Business Operations Senior Associate
Industry: Pharma/Biotechnology
Location: Foster City, CA
 
General Position Summary / Purpose:

The Development Business Operations Senior Associate in the Document Management Team (DMT) will collaborate with Development Business Operations leadership, Clinical Records, Clinical Operations Teams, and Development Business Operations functional groups in the planning, development, and implementation of standards, processes, and projects for DMT designed to ensure the effective and efficient archiving of clinical agreements and related information created in support of clinical research. Comply with relevant regulatory, legal, country specific and corporate requirements to produce and maintain inspection readiness for clinical records.

Key Accountabilities / Core Job Responsibilities

• Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements
• Collaborate with Development Business Operations leadership, Development Business Operations functional groups, clinical operations teams, and functional areas outside of Development Business Operations to ensure compliance with policies, procedures, and the practices of records management/TMF archival initiative
• Work with management and DMT personnel in the development, implementation and maintenance of classification and filing systems to meet administrative, research, regulatory, legal, and financial requirements (e.g. filing of agreements in legal archive, Apttus, and eTMF GDAR system)
• Work with management to manage business continuity procedures, including management of paper agreements
• Perform central intake activities including creating records of incoming documents within the first business day of receipt, filing of incoming documents, and retrieve copies of paper protocol agreements from TMF room for Apttus filing
• Responsible for ensuring the central intake report is generated daily and published in a timely fashion
• Evaluate regulatory and business recordkeeping, archiving requirements, and organizational objectives and ensure Development Business Operations DMT is aligned with all
• Responsible for the continued maintenance of eTMF (GDAR) and Apttus contract filing
• File incoming documents and retrieve copy of paper protocol agreements from TMF room for Apttus filing
• Ensure record filing is kept up to date is performed accurately by DMT members
• Develop and maintain quality assurance and control plans
• Responsible for monitoring accuracy of the team’s work by providing reports and metrics to the management team
• Responsible for leading assigned meetings/projects and will mentor/help more junior staff with complex initiatives
• Develop and maintain department process guidance, training materials, policies and procedures, and other quality documents
• Define and manage processes associated with the storing, archiving, indexing, scanning, and classifying clinical records
• Manage the off-site storage of records for Development Business Operations agreements and collaborate closely with Clinical Records team to ensure proper process is in place for off-site archival of paper agreements
• Collaborate and partner with the Information Technology (IT) GDAR Team, through stellar communication and solid project management. Resolve efficiently any issues encountered by collaborating with IT in the improvement of processes, procedures, and effective use of available information technologies
• Operate as the Subject Matter Expert (SME) in the electronic TMF (eTMF)
• Respond to internal and/or external information inquiries related to contract filing and records retention of those agreements; supports internal and external audits and inspections, including provision of data on contract filing
• Manage the DMT mailbox by responding to daily email inquiries, review of incoming agreements for technical review and 30 day contemporaneous filing in eTMF (GDAR) and Apttus
• Participate in the development, implementation and maintenance of internal systems and processes used to manage collections of agreements and filing of documents to GDAR and Apttus
• Track and maintain departmental metrics related to operational activities, progress of contract filing and archive, quality measurements and other variables. Develops appropriate tool sets for capturing metrics and generating reports.
• Responsible for the day-day activities associated with the quality check of clinical agreements and management of contract filing and archival
• Ensure appropriate documentation completed to track archival of files
• Support Development Business Operations Functional Teams and Clinical Operations Study Teams in understanding TMF-related responsibilities, requirements and expectations
• Manage Development Business Operations TMF protocol list for legacy and active protocols and Development Business Operations TMF Comprehensive Review Trackers and Agreements Missing in TMF
• Provide management with DMT TMF metrics; completeness and quality of TMF documentation and content, including the percent completeness and risk level of outstanding items on a periodic and/or adhoc basis as requested by management
Qualifications / Requirements
• 5 plus years of project or clinical trial management experience
• 5 plus years of project leadership experience with PMP preferred
• 3 - 5 years in management position responsible for the establishment and maintenance of procedural documents
• 3 plus years of Clinical Research Associate (CRA) or relevant records management/ TMF management experience equivalent experience preferred
• Exemplary interpersonal skills with proven demonstration
• Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management
• Expert in Microsoft programs including, but not limited to, MSWord, PowerPoint, Visio, Access, and Excel
• BA/BS required
• The Sr. Associate needs subject matter expertise in Trial Master File (TMF) Quality and Records Management.
• The Sr. Associate has foundational skills in Influencing and Leadership, and demonstrates advanced Teamwork skills. Must have foundational abilities in all TMF and contract filing technical competencies, including Quality Management and Change Management.

Job Requirements

 
Clinical Contracts Associate - III Apply now