Parexel
Early Development Lead Clinical Data Manager - FSP
United States - Remote
Sponsorship not specifiedDetected 6 hours ago
SwiftGCPNegotiationForecastingClinical TrialsClinical ResearchResearchLeadershipCommunicationProblem SolvingTime ManagementMicrosoft Office
About the role
- From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
- Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
- We take our work personally, we do it with empathy and we're committed to making a difference.
Responsibilities
- Parexel is looking for an Early Development Lead Clinical Data Manager to join our growing FSP Team in US.
- The Early Development Lead Clinical Data Manager provides technical expertise in all aspects of Data Management.
- Manage timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock.
- The Early Development Lead Clinical Data Manager works with minimal guidance from their Line Manager and/or Subject Matter Experts.
- Manage and coordinate the integration and utilization of all ancillary systems as appropriate.
- Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan.
- Review of the Master Services Agreement, Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators.
- Maintain inspection-ready Trial Master File.
- Drive and implement Corrective/Preventive actions for study, and work toward alignment across Parexel as appropriate - share lessons learned across multiple projects within a program or therapeutic area
- Collaborate with Delivery Lead and/or line management to ensure appropriate project level resourcing of staff and staff assignments.
Requirements
- Proven record of leading project and program teams
- Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products
- Bachelor's degree and/or other qualifications in a science or clinical related industry
- Minimum 3 years of relevant experience
- Must have early development experience
Skills
- Strong negotiation skills and ability to influence in order to achieve mutually beneficial results
- Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
- Learning ability and knowledge sharing approach; swift understanding of technologies and new processes
- A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments
- Proficient presentation skills
- Commitment to first time quality, including a methodical and accurate approach to work activities
- Time management and prioritization skills, in order to meet objectives and timelines
- Ownership and accountability for Key Accountabilities in Job Description
- Ability to travel as required
- Written and oral fluency in English
- Knowledge and Experience:
- Strong experience in clinical research industry
Benefits
- At Parexel, we all share the same goal - to improve the world's health.
- Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies.
- Review and analyze metrics to derive meaningful summary of study health and trends.
Company info
- When our values align, there's no limit to what we can achieve.
Equal opportunity
- Parexel is an equal opportunity employer.
Visa & Work Authorization
- Review of the Master Services Agreement, Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators
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This listing is sourced directly from Parexel's careers page and normalized into a canonical job model.