When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. 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.
Parexel is looking for an Early Development Lead Clinical Data Manager to join our growing FSP Team in US.
Job Overview
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. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management’s single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness and quality. The Early Development Lead Clinical Data Managerworks with minimal guidance from their Line Manager and/or Subject Matter Experts. DMs may act as a mentor for ADMs or other DM peers
Key Accountabilities:
Cross-functional DM Leadership through Database Set up, Conduct and Study Close- Out
Manage and coordinate the integration and utilization of all ancillary systems as appropriate.
Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan.
Review and analyze metrics to derive meaningful summary of study health and trends.
Review of the Master Services Agreement, Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators.
Attend cross-functional meetings. Prepare Meeting Agendas and Minutes, comply to action and decision logs
Bid Pursuits and Proposals
Portray Parexel's technical and operational expertise and capabilities, and tailor to meet sponsor's specific needs.
Provide input to bid pursuit slides
Present with confidence and as a cohesive Parexel team with other functions.
Project Quality Management and
Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
Compliance
Maintain inspection-ready Trial Master File.
Identification of quality issues, ensuring they are raised in relevant system and closed according to requirements.
Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies.
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
Project Financial and Resource Management
Collaborate with Delivery Lead and/or line management to ensure appropriate project level resourcing of staff and staff assignments. Identify and request functional staff necessary for the project team.
Collaborate with Delivery Lead and/or line management to determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope
Company Initiatives
Provide Data Management functional input, considering the impact of the initiative and the impact on Data Management and Parexel as a whole.
Collaborate with other functions as appropriate to provide meaningful functional feedback on the initiative.
Ensure Parexel-requested information entered in management systems is accurate and regularly updated
Training
Maintain training compliance as per Job Roles assigned, including On-the-Job training.
Deliver Project Specific Training to internal DM team.
Address training needs, as per Development Goal/s identified.
Deliver On-the-job training where needed/requested
Skills:
Strong ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
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
Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust
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
Proven problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses
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
Proven record of leading project and program teams
Good understanding and application of Parexel project tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.
Good understanding of Clinical Study Team roles outside of Data Management
Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
Awareness of SDTM/CDISC/CDASH standards
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
Education:
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
EEO Disclaimer
is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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