Development Business Operations Associate

MEDVACON Life Sciences; Foster City (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

MEDVACON Life Sciences is seeking a Development Business Operations Associate for a hybrid role in Foster City, CA. This position requires maintaining compliance with clinical agreements and managing data efficiently.

The ideal candidate will have a BA/BS degree and over 5 years of project management and data science experience, with strong knowledge of FDA regulations. Responsibilities include data analysis, collaboration with leadership, and adherence to regulatory standards.

Qualifications

• 3-5 years of relevant experience.
• 3+ years of data science experience.
• 5+ years of project management experience, PMP preferred.
• 3+ years of CRA or TMF management experience preferred.
• Knowledge of FDA clinical trial regulations.

Responsibilities

• Maintain knowledge of GCP, ICH, and GLP regulations.
• Collaborate with leadership and clinical operations teams.
• Work on filing systems that meet various requirements.
• Data mining and enhancing data collection procedures.
• Perform ad-hoc analysis of department data.

Skills

Data science experience

Project management

Clinical Research Associate (CRA) experience

Knowledge of ICH and GCP guidelines

Education

BA/BS degree

Tools

Data visualization tools

Job description

Development Business Operations Associate

MEDVACON Life Sciences works with many leading pharmaceutical companies to hire consultants, contractors, and full-time employees to join their organizations.

One of our pharmaceutical clients is looking to fill a Development Business Operations Associate position ON-SITE in Foster City, CA. This is a HYBRID position, worked two days per week in office, and the rest is worked remotely.

Location: HYBRID – 2 days per week on-site in Foster City, CA

Contract Duration: 6 months

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 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)
• Data mining/modeling (e.g., statistical models) and enhancing data collection procedures to identify patterns and extract knowledge from large data sets
• Processing, cleansing, and verifying the integrity of data used for analysis
• Doing ad-hoc analysis of department data and presenting results in a clear manner
• 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
• Collaborate with management to generate central intake report on a daily and published in a timely fashion
• Responsible for keeping DMT Master Inventory up to date and accurate
• 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
• Work with management to develop and maintain quality assurance and control plans
• Responsible for monitoring accuracy of the team’s work by providing reports and metrics to management team

Qualifications / Requirements:

• 3-5 plus years of relevant experience
• BA/BS required
• 3+ years of data science experience with common data science toolkits and data visualization tools
• 5+ years of project management experience with PMP preferred
• 3+ years of Clinical Research Associate (CRA) or relevant records management/TMF management experience preferred
• Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management

W2/1099 CONTRACT CANDIDATES ONLY!!! NO C2C/CONSULTANTS!!!