Associate Manager, Clinical Data Sciences
Company: Premier Research
Location: Boston
Posted on: January 15, 2021
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Job Description:
DescriptionPosition at Premier Research Group LimitedPremier
Research helps highly innovative biotech and specialty pharma
companies transform life-changing ideas into reality. We have
positioned ourselves right in the middle of the action, targeting
unmet needs in Analgesia, Neuroscience, Oncology, Dermatology,
Pediatrics, and Rare Diseases.We---re looking for an energized
Associate Manager, Clinical Data Sciences to join our team This is
an exciting opportunity to join a dynamic and innovative team and
grow with a forward-thinking organization, changing to course of
medicine.Working at Premier Research means being an individual -
you will be recognized for what you do and the impact made. You
will be working in a friendly environment with colleagues who are
genuinely supportive, regardless of location or seniority.Premier
Research is on an exciting journey - there is a true buzz
throughout the company. Come and be part of itAs an Associate
Manager Clinical Data Sciences, you will have the opportunity to
serve as a member of the project team with the lead responsibility
for reviewing CRFs, data listings, and databases to ensure that all
captured data follow the rules outlined by the protocol and data
management plan. You'll also prepare data management plans, data
entry guidelines, data management reports and other documents
required for preparing and completing databases. Where a Biometrics
Project Manager is allocated on a study, you'll act as the Data
Operations point of contact for all data management
responsibilities when designated as the Data Management Team Leader
(Core Team Representative). You will also be able to be a Line
Manager and Mentor to a small group of less experienced team
members.What you---ll be doing:Coordinate and act as point of
contact for all data operations responsibilities related to Data
Management for multiple studiesParticipate in resources allocation
and utilization issues with the management team for data
managementManage personnel (Assoc. Data Coordinators, Data
Coordinators and Senior Data Coordinators) with respect to data
management skill development & recruitment, training, career
development, issue resolution, performance management, billing
practices, and adherence to PRG SOPs/Guidelines and GCP standards;
lead, Mentor and train junior staff in an aspirational and
empowering working environmentPrepare data management plans, data
entry guidelines, data management reports and other documents
required for preparing and completing databasesReview draft
protocols and CRFs for potential data collection and
representation, database structure or data entry problems, and
provide feedback to the project team; review CRFs, data listings,
and database to ensure all captured data follow the rules outlined
by the protocol and data management planGenerate paper and
electronic queries to appropriate internal or external personnel
(investigational sites, vendors, Clinical Research Associates
(CRAs), client representatives) to resolve problematic data
identified during every aspect of the data management process;
review responses to queries for appropriateness, resolve any
discrepancies and modify the database accordinglyTrack CRFs as they
are processed through the Data Management departmentReconcile 3rd
party data with CDMS data.Review and contribute to the
development/update of department SOP---s and Working
GuidelinesParticipate in project costing estimates and proposal
review in the business development/change order processParticipate
in Proposal Defense and Capabilities presentationsInteract with the
Biometrics Project Manager on a continual basis throughout the
course of the studyAdminister financial compensation for direct
reports and propose adjustments (e.g., promotions, market
adjustments, etc.) to departmental managementYou---ll need this to
be considered:Educated to Bachelor---s degree level or equivalent
along 5 years data management experience including 3 years--- in
clinical research, drug development or healthcare
environmentWorking knowledge of FDA Guidance Documents / EU
Directives / ISO14155 regulations, drug / device development, and
clinical monitoring procedures; understanding and experience with
up to date MS Windows Operating Systems and applications and at
least one Database Management System (e.g., SAS, Oracle,
Clintrials, Oracle Clinical, eDM, etc.)Proficiency with the
development and review of Informed Consent Form templatesKnowledge
of ICH / GCP regulationsKnowledge of web based communication tools
for conferencesFluent verbal and written English as well as the
local language(s) required for clinical trial submissions.Excellent
team player, collaborative and able to build an effective
team.Ability to multitask and work effectively in a fast-paced
environment with changing priorities.Strong verbal and written
communication and negotiation skills.Excellent organizational and
time-management skills, able prioritize work to meet
deadlines.Accountable, dependable and strong commitment.Customer
service focused approach (both internally and
externally).LI-BL1
Keywords: Premier Research, Boston , Associate Manager, Clinical Data Sciences, Executive , Boston, Massachusetts
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