Brenda Clark Email & Phone Number

Marlborough, Massachusetts, United States

Supply Chain Specialist-ICS MetallizationCollaborated with business units to maintain accurate stock capacity of all materials purchased and manufactured at the Dupont site in Marlborough, MA. Ensured production requirements and inventory plans met demand from sales and allocated materials to customers.

Marlborough, Ma

Worked closely with the Run Plant Engineers (RPE) in the setup process of the chemicals for five product lines, utilizing the bill of materials (BOM). Maintained compliance by ensuring that the team followed the Material Safety Data Sheet (MSDS) and the Certificate of Analysis (COA), according to the materialhandling safety procedures in support of good manufacturing practice (GMP) and the Environmental Health and Safety (EH&S).

Marlborough, Massachusetts

Work closely with the Run Plant Engineers, (RPE) in the setup process of the raw materials for five product lines. Maintain compliance by ensuring that the Material Safety Data Sheet (MSDS), the Certificate of Analysis, (COA) and the material handling safety procedures are followed to support good manufacturing practice, (GMP), and the Environmental Health and Safety, (EH&S) standards.

Marlborough, Massachusetts

Supported the APT and the IT product line in the completion of the batch setup of the chemical requirements, provided quality deliverables, driving customer satisfaction. Sustained compliance by ensuring that the Material Safety Data Sheet (MSDS), the Certificate of Analysis, (COA) and the material handling safety procedures were followed to support good manufacturing practice, (GMP) and the Environmental Health and Safety, (EH&S) standards.

Cambridge, Massachusetts

Contributed to the resourcing project by participating in the development of a flexible resource model, whereby leveraging strategic partnerships with vendors and focusing internal resources on higher value-added activities. Key results:Within the first month of accepting the position, researched colleges and universities in New England area, and established a network to recruit for Intern and Co-op positions in MA. Successfully filled 4 Intern and 4 Co-op positions across two sites… Show more Contributed to the resourcing project by participating in the development of a flexible resource model, whereby leveraging strategic partnerships with vendors and focusing internal resources on higher value-added activities. Key results:Within the first month of accepting the position, researched colleges and universities in New England area, and established a network to recruit for Intern and Co-op positions in MA. Successfully filled 4 Intern and 4 Co-op positions across two sites each year.Implemented a Fellowship program for the Clinical Documentation group in the US corporate office. The focus of the program was for the Fellow to gain a broad set of skills and training of the documents required to develop and maintain drug products according to health authority requirements. Created a resource tracking system and a SharePoint area where the budgetary data was posted, which enabled the managers to track the projected spend versus the actual spend for all contractual positions.Acted as a liaison between the US Clinical Documentation Group and a leading vendor, aiding in the internal engagement plan targeted at key global stakeholders to meet specific corporate goals and developing a successful strategic partnership. Show less

United States

Supported the Clinical Trials Operations Group Leader and the Clinical Trial Operations Managers by ensuring that the clinical and data management activities for clinical trials (phase I to III) from start-up to closeout were completed utilizing several systems and reporting tools. Key results:Created a plan to identify the clinical experience and expertise within the Clinical Trial and Operations department, which could be shared across several therapeutic areas to fulfill a resource… Show more Supported the Clinical Trials Operations Group Leader and the Clinical Trial Operations Managers by ensuring that the clinical and data management activities for clinical trials (phase I to III) from start-up to closeout were completed utilizing several systems and reporting tools. Key results:Created a plan to identify the clinical experience and expertise within the Clinical Trial and Operations department, which could be shared across several therapeutic areas to fulfill a resource need, saving on the annual budget for recruitment, on-boarding and training new associates and to retain talent by developing individual/group clinical skills.Effectively mentored the individuals stepping into the new role of Trial Management Associate while conducting the data management training for the new Clinical Trial and Operations Managers.Created a process for the reporting of the quality and safety data for the clinical studies that were fully outsourced. The process ensured that the quality and safety data for fully outsourced studies were maintained in the same clinical database as fully insourced clinical studies. Delivered quality reports on a monthly basis for 18 studies from Phase I to Phase III to senior management to ensure 100% compliance with the quality and safety data reporting. Show less

Cambridge, Massachusetts

Ensured essential reporting of adverse events, dose limiting toxicities, protocol deviations and of patient status by communicating findings observed either at the site or in reviewing data in-house to appropriate sanofi-aventis staff in a background a timely manner. Key results:Key contributor to the development of a standard validation process for Oncology studies managed internally and best practices in study validation focused on patient safety for the clinical trials with… Show more Ensured essential reporting of adverse events, dose limiting toxicities, protocol deviations and of patient status by communicating findings observed either at the site or in reviewing data in-house to appropriate sanofi-aventis staff in a background a timely manner. Key results:Key contributor to the development of a standard validation process for Oncology studies managed internally and best practices in study validation focused on patient safety for the clinical trials with activities outsourced, streamlining the essential steps in the process of the development of the data validation plan for all projects. Show less

United States

Dedicated support in the development of a team of data acquisition professionals, including the workload evaluation, resource consolidation, recruitment of full-time and temporary staff and the performance evaluations.