Essential Functions
● Provide expert review guidance fproduction of Data Management
deliverables including CRF/e-CRF, database design set-up, validation
definition programming, Data Management Plan database deliverables to
internal external customers. Provide technical advice solutions with
internal external customers to solve problems improve efficiency.
Ensure that staff is trained compliant with current operating procedures
work instructions project scope of work. Identify address
professional development/training needs of staff. Mentstaff members to
develop Data Management process, system, drug development expertise.
Provide operational input proposals scope of work. Participate in
proposal defenses.
● Hold at least bi-monthly meetings with direct reports to discuss, at a
minimum: project status, including timelines, delivery updates, financial
aspects of the group project, potential risks, associated mitigation
support required; status of any initiatives that they may be involved in; the
teams utilization rates; the direct reports training other administrative
obligations, such as Standard Operating Procedures (SOPs) corporate
training mandates; personnel issues; career training objectives.
● Develop implement plans fmeasuring improving employee engagement,
ensuring global consistency.
● Collaborate with project leads to address work scheduling fcurrent
projected projects, staffing needs, technological needs, projected peak
workloads, ensuring global consistency, where possible. Develop manage
associated action plans to hold members accountable.
● Efficiently conveying messages from leadership to direct reports teams,
as well as effectively communicating issues opportunities up to leadership.
● Might be needed to serve as the designated substitute alternatively
ensure coverage is in place fdirect reports during their absence in case
of turnover.
● Attend participate in Bid Defenses, Kick off Meetings (KOM), as
applicable. Support Request fInformation (RFI), Request fPricing (RFP),
budgets, as requested.
● Participate / Support internal external audits inspections, as
required. Also ensure required staff is assigned, trained prepared to
support.
Qualifications
● Bachelors Degree Clinical, biological mathematical sciences related
field, nursing qualification Req
● 7 years of relevant work experience including people management. Equivalent
combination of education, training experience.
● Advanced knowledge of Data Management processes systems.
● Solid understanding of clinical drug development process production of
Data Management deliverables
● Proven Staff management skills, strong leadership, motivational
influencing skills.
● Strongganizational skills, metrics calculations, time management
skills.
● Strong verbal/written communication skills.
● Ability to work on multiple projects manage competing priorities
effectively
● Effective mentoring developed coaching skills.
● Ability to achieve results through proactive communication facilitation
in a matrix service delivery environment with shared accountabilities.
● Sound judgment, decision-making problem-solving skills.
● Ability to establish maintain effective working relationships with
coworkers, managers, clients
● Ability to follow instructions/guidelines, utilize initiative work
independently.
● Understanding on basic Project Finance (EAC, forecasting, burn-rate
monitoring recognizing & pursuing OOS where appropriate)
● Ability to drive business financial results – short long term.
● Ability to proactively evaluate risks potential issues seek
solutions discuss appropriately with direct reports, colleagues,
customers.
● Demonstrates good judgement in requesting input from senistaff. When
requesting input, ensure clearly laying out the issue required background
details, articulating what support is needed; what are the recommended
actions.
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