Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
To learn more about us, please visit us at http://www.pharmacyclics.com/
General Position Summary / Purpose:
The Clinical/Trial Master File Project Manager will c ollaborate with CRM staff, clinical operations teams, and functional areas outside of Global Development Operations (GDO) in the planning, development, and implementation of standards, processes, and projects for Clinical Records Management (CRM) designed to ensure the effective and efficient archiving of clinical records and related information created in support of a clinical investigation. Comply with relevant regulatory, legal, country specific and corporate requirements to produce and maintain inspection ready clinical records.
Key Accountabilities / Core Job Responsibilities:
- Collaborate with CRM staff, clinical operations teams, and functional areas outside of Global Development Operations (GDO)to ensure compliance with policies, procedures, and the practices of PCYC’s records management program
- Work with management and CRM personnel in the development, implementation and maintenance of classification and filing systems to meet administrative, research, regulatory, legal, and financial requirements (e.g. Reference Model for clinical TMF)
- Work with Facilities and Security personnel to manage business continuity procedures, including Paper Records Room security and access, environmental controls, disaster preparedness, and disaster recovery
- Evaluate regulatory and business recordkeeping, archiving requirements, and organizational objectives and ensure CRM is aligned with all
- Develop and maintain department manuals, 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 and the contract with the storage vendor, including vendor oversight
- Collaborate and partner with the department of information technology (IT) issues 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 Business process administrator in the electronic TMF (eTMF)
- Respond to internal and/or external information inquiries related to records; supports internal and external audits and inspections, including development and implementation of CAPA results activities
- Manage the transition of proprietary information for acquisitions, divestitures and licensing of compounds related to clinical records
- Participate in the development, implementation and maintenance of internal databases used to manage proprietary collections of documents
- Track and maintain departmental metrics related to operational activities, quality measurements and other variables. Develops appropriate tool sets for capturing metrics and generating reports.
- Track and maintain study-specific TMF management metrics related to operational activities, quality measurements and other variables. Develops appropriate tool sets for capturing metrics and generating reports.
- Lead the team of Clinical Record Technicians in day-day activities associated with the quality check of clinical records and management of the paper record room.
Qualifications / Requirements:
- 5 plus years of people, project or clinical trial management experience
- 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
- Proficiency in MS Project and standard desktop tools including, but not limited to, MSWord, PowerPoint, Visio, and Excel
- BA/ BS required
Equal Opportunity Employer Minorities/Women/Veterans/Disabled