Manager I, Clinical Sample & Data Management

Position Description: Oversight of the data management function within the Clinical Sample & Data Management group located in Mountain View, CA. This group supports all clinical projects within MedImmune Inc. including all therapeutic areas; Infectious Diseases including Vaccines, Oncology, and Inflammatory Diseases as it applies to the collection and analysis of clinical specimens.Major Duties and Responsibilities• Standardize data management procedures ensuring the development of a data management control system within CS&DM.• Oversee and manage a staff of Data Management Associate including coaching, goal setting, career development and semi annual performance evaluations. Staff management includes setting priorities and goals for the group.• Be able to perform, supervise and coordinate all aspects of clinical specimen data management including study participant demographics and analytical results.• Oversee all aspects of systems utilized by the group including the on-going management of the current relational database used to track clinical specimens, participant demographics and analytical results and the on-going development of new LIMS.• Work closely with peers within CS&DM, Clinical Operations, Biostatistics, Clinical Data Management and Programming.• Work closely with CS&DM Data Management staff and Project Management staff to set and meet all data transfer deadlines.• Need to be able to interpret and apply SEC/Coding/Data Management Guidelines and Data Handling Guidelines. • Responsible for study startup documentation (Data Management or Handling Guidelines for each Clinical Study as well as agreed upon Data Reporting Specifications), data cleaning, Sample Document tracking, database QC, compilation and maintenance of data management binders and database lock.• Supervise the resolution of data discrepancies with both study clinical sites and the Clinical Operations database.• Identify errors and inconsistencies in demographic data and ensure their resolution• Prepare materials for presentation at internal Department meetings and inter-departmental meetings within MedImmune.• Develop and monitor study metrics, ensure appropriate training for the CS&DM Data Management team and all other user of the CS&DM database or LIMS.Requirements/Qualifications:Education & Experience: • Bachelor’s degree in science related field and /or a degree or certification in Data Management.• At least five years of relevant data management experience in the biotech or pharmaceutical industry, a Master’s degree would be a plus.• Extensive experience with data management concepts, practices and procedures a must.• Desire to stay current with industry practices.Special Skills/Abilities: • Able to work independently and with a great deal of flexibility. • Able to find creative solutions to an ever changing data management landscape.• A wide degree of creativity and latitude is expected.• Able to take responsibility for your own development and training.• Able to rely on extensive experience and judgment to plan and accomplish personal and departmental goals.• Clear understanding of what it means to be part of a service organization and that strong negotiation skills are a must.• Always striving to find value added resolutions or solutions to on-going issuesSupervision: • Demonstrates strong leadership qualities and interpersonal skills. • Enjoys and is energized by working with employees being promoted out of the lab and into data entry functions.• Priorities work for direct reports such that deadlines can be met.• Capable of developing methods for oversight of direct reports performanceCLICK HERE TO APPLY MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Manager I, Clinical Sample & Data Management Location:  US-CA-Mountain View - NON SALES Status:  Full Time, Employee Job Category:  Sales/Retail/Business Development