Covance Sr Director, Global Clinical Programming and Analytics in Chantilly, Virginia
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We are recruiting for our Biometrics team in Princeton, NJ and are currently seeking to hire a Sr. Director, Global Clinical Programming and Analytics.
This is a full time position, based in our Princeton, NJ location. Home-based can be considered.
Job responsibilities may include:
Leadership position within the Clinical Data Management (CDM) organization with responsibility for EDC, SAS, and reporting project coverage of all full service Covance studies.
Serve as the global technical leader on all technology issues impacting Clinical Data Management process performance.
Identify and implement proactive, tactical technology and training strategies based on productivity metrics and volume forecasts; develop Technical Plans that will deliver clear solutions to issues challenging productivity, quality, client satisfaction and employee satisfaction
Serve as senior global technical partner in Clinical Data Management and Clinical Informatics to ensure effective planning, design ,implementation and training
Provide technical input to the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications when requested.
Provide technical input into the development and testing of data management systems, edit data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
Provide data/information to assist Clinical Data Management (CDM) and Clinical Data Management in building the business case for strategic business decisions, capacity management and utilization.
Responsibility for the recruitment, training, development, and performance review of personnel in the Global Clinical Programming and Analytics function
Collaborate and coordinate with CDM and IT on process and implementation of clinical data management systems
Owns the voice of employees globally into management for organization, prioritization and implementation/training/tracking plan for resolutions
Owns the current and forward looking voice of client satisfaction for programming and systems performance as it relates to performance and results for the client study
Provide overall leadership for the Global Clinical Programming and Analytics (GCPA) function and associated roles within the Clinical Data Management operations teams.
Oversee the development, implementation and adherence to project plans and performance indicators within the clinical operating unit.
Provide HR leadership, budget management, administrative and productivity management to GCPA team
Responsible to liaise with other functional counterparts as necessary to deliver successful projects/programs for the client
Assist project teams in problem resolution such as deviation from project plans.
Ensure project deliverables are met according to both Covance and client contractual expectations.
Provide advanced planning and risk management for programming projects—like issue escalation and resource management
Own successful achievement of financial and productivity goals in annual budget as it specifically applies to the Global Clinical Programming and Analytics (GCPA) area
Interact and collaborate with other project and specialty team members (clinical, statistics, drug safety, etc.) in order to provide counsel on technical issues impacting their performance and deliverables
Support the technical mentoring of GCPA and CDM staff in regional locations
Maintain technical data management competencies via participation in internal and external training seminars
Review literature and research technologies/procedures for improving global data management practices
Provide analysis and strategic input on bid proposals, when requested and be the programming leader for all bid-defenses, as required
Any other duties assigned by supervisor
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). MBA or other Advanced Degree strongly preferred
Broad knowledge of drug development process
Financial understanding of global clinical development budgets
Proven expertise in financial control procedures
Proven ability to understand and communicate corporate policies
Thorough knowledge of effective clinical project management and data management practices
Strong knowledge of resource management systems
Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Proven background in performance within complex global management matrix
Proven background in positive leadership and organizational development in alignment with corporate and business-unit HR strategies
Minimum of ten (10) years relevant clinical research experience in a pharmaceutical company/CRO including at least five (5) years of clinical data management, Bio-Metrics or IT responsibility In lieu of the above requirement, candidates with >5 years supervisory experience in a health care setting and seven (7) years clinical research experience including >4 years of project management experience (international clinical trial management experience preferred) in the pharmaceutical or CRO industries will be considered.
Extensive industry experience in EDC process and technology implementation
Proven background in managing complex programming budgets, teams and on-time deliverables
Experienced client-focused background relevant to a large CRO
Excellent leadership skills
Strong financial analytical skills
Experience in managing global drug development programs.
Excellent oral, written and presentation skills
Excellent planning and organizational skills including the skills necessary for implementing corporate change
Demonstrated ability to lead by example and to encourage team members to seek solutions.
Proven interpersonal skills
Demonstrated ability to lead and line manage staff in a global multi-office environment
Demonstrated ability to handle multiple competing priorities across clinical operating units
Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
Demonstrated ability to function as a member of a senior global clinical leadership team
Strong ability to understand and assess technology alternatives and implication for current processes
Experience in the creation of new processes
Proven ability to negotiate with clients in a professional manner
Job Number 2018-21978
Job Category Other
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.