Early Development Lead Clinical Data Manager - FSP

Parexel is looking for an Early Development Lead Clinical Data Manager to join our growing FSP Team in US.This is a hybrid role (2 days per week) in West Point, PA or Rahway, NJ.

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

#LI-Hybrid

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.