Reports To (Position): Senior Director Clinical Data Management
Location: South San Francisco
Department Name: Data Management, Biometrics
HR Designations: Pay Status – Exempt
Objective of Position
A role to lead and coordinate operational activities (study and global level) related to Data Management associated systems and processes to ensure quality delivery of clinical studies.
Essential Duties/ Responsibilities
- Proven Conceptual, Analytical and Strategic thinking; concern for standards and willingness to learn from others.
- EDC System Administration, including performing and/or overseeing Site and User accounts.
- Technical skills and knowledge expertise in enablement and study management areas (e.g. Study Management, EDC, IxRS, Data Standards, CTMS etc).
- Collaborate with IT and Clinical Quality Assurance on system validation.
- Participate in audits as Data Management and Systems Subject Matter Expert.
- Good understanding of clinical data flow.
- Proven Clinical Data Management experience (e.g. as a Lead Data Manager).
- Create process maps and related documentation including documents supporting training development.
- Participate in vendor management, ensuring requirements are met and consistency.
- Accountable for end to end mapping of study systems per SMT process.
- Accountable for ensuring that data management services meet procedural, business and regulatory requirements.
- Work with internal and external partners on local and global initiatives related to systems and process used by clinical studies across different phases of drug development and in different therapy areas.
- Coordinate with Lead Data Managers and Biometrics Leadership to deliver consistent, effective and efficient enablement services and partner with key stakeholders (project and function).
- Provide tailored solutions of the most efficient procedures and best practices to support study delivery if needed; this includes ensuring sufficient and appropriate Acerta Pharma processes, SOPs, standards and templates are provided to internal and external partners (e.g. CRO studies).
- Lead and/or participate in activities that ensure quality consistency and integration of study data to agreed time, cost and qualityobjectives.
- Work closely with different roles, delivery partners and business support networks.
- Contribute to activities performed by Data Management to ensure process compliance; lead and/or contribute to activities supporting Audits & Inspection Readiness, audits, regulatory inspections.
- Collaborate with Compliance and other cross-functional stakeholders; lead and/or coordinate activities in support of any local or national legislation reporting requirements for systems, business process.
- Liaise with Process/System Owners to the development, enhancement, implementation and training of global/local processes, procedural information and other competency programs to embed understanding and to ensure compliance; coordinate study compliance improvement activities.
- Demonstration of ability to work and lead cross-functionally, e.g. with internal and external partners,onglobalstudies,acrossdifferentphasesofdrugdevelopmentintermsofprocessesand systems.
- Work with Data Management Leadership and global cross functional colleagues to identify issueswithprocesses,analyzegaps,solicitideas,formulaterecommendationsandassistwith implementation of solutions.
- Generate and review Data Management processes including SOPs and Working Instructions ensuring compliance with regulations and incorporating efficiencies and bestpractices.
- Potentially serve as Lead CDM for study(ies).
- Medidata Rave required, in addition Bioclinica Express and other EDC systems preferred.
- IxRS systems.
- CTMS systems.
- External Data Vendors, for example Central Laboratories.
Skills and Capabilities
- Proven Clinical Data Management experience.
- Proven excellent negotiation, interpersonal, problem solving and conflict resolution skills.
- Proven change management skills and championship of continuous improvement.
- Ability to work collaboratively, motivate and empower others to accomplish individual, team and organizational objectives.
- Excellent verbal and written communication and presentation skills.
- Proven ability to prioritize and manage multiple tasks with conflicting deadlines.
- Demonstrates good knowledge of GCP, CDISC, CDASH, SDTM.
- Proactively identifies risks and issues and possible solutions.
- Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.
- Demonstrated Project Management skills.
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
- Overall 10+ years clinical research experience.
- Minimum 5 years’ experience as a DM Lead of multiple studies including overseeing vendors.
- Minimum 5 years’ experience in system process experience, having led or actively participated in a computer system validation preferably of a DM system with QA and/or IT.
- Knowledge of GCP/FDA/ICH regulations required.
- Extensive knowledge of Clinical Trial systems (e.g. EDC, Clinical Trial Management Systems, eTMF, MedDRA and WHODrug, etc).
- Extensive knowledge of data management, clinical operations, safety operations, and clinical processes.
- Proven knowledge about project management tools and processes.
- Proven leadership capabilities (people and project), including team facilitation.
- Exhibit of Acerta Values and Behaviors.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.