Manager, Clinical Data Management jobs in United States
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Syneos Health · 1 month ago

Manager, Clinical Data Management

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The Manager of Clinical Data Management is responsible for overseeing project launch, conduct, and closeout activities, ensuring compliance with quality standards and managing project budgets and resources.

BiotechnologyHealth CarePharmaceuticalTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Ensures project launch, conduct, and closeout activities are performed according to the Customer's and the Company's contractual agreement. Ensures that all project-related data management tasks are completed in accordance with internal and customer quality standards, Syneos Health SOPs, and all pertinent industry/regulatory guidelines and legal requirements from commencement to closure of a project. Ensures project documentation is filed on an ongoing basis and the TMF is maintained in an inspection ready state
Manages multiple projects ranging in size and complexity from single service studies, to multiple global projects within a program, with interaction from supervisor as required · May serve as the sponsor liaison
May proactively manage the scope, budget, and resource for their assigned projects under the guidance of an Associate Director/Director. Manages the financial aspects of the assigned projects, including ensuring projects maintain the correct level of gross profit, and changes in scope are applied as necessary. Ensures that customers are invoiced in a timely manner
Identify data management project issues and alert Manager (Senior Department Management) with a view to remedial action. May serve as point of escalation for individual projects
Ensure effective communication between departments and with Sponsor to ensure a high level of client satisfaction through successful execution of projects
May review Protocol, Data Management Plan, CRF and Edit Check Specifications to ensure consistency across documentation
Ensures a review of relevant project Data Management study files for currency and accuracy, including development of a corrective action plan for quality issues or non-compliance
Line Management and functional support of assigned staff. Interview, onboard and train new staff as appropriate. Oversee professional development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching
Mentors staff in general team leadership skills, project management skills, internal Company processes, and for project specific tasks
Manage the resources / workload of assigned team and projects, assigns tasks to team members, manage billable and non-billable time, and subsequently monitors productivity / utilization, timeliness, and quality
Maintains and evaluates project progress. May work with PDMs to prepare for and attend Project Review Meetings
May participate in Sponsor or regulatory audits
May represent Clinical Data Management at Business Development and Sponsor-related meetings with support from the Associate Director/Director
May perform training for data management staff to internal and external audiences as required
Maintains departmental resourcing tracking tools
May lead or participate in process improvement/departmental strategic initiatives to support the Business. This may include the development of departmental technologies, SOPs, processes and procedures
Maintains proficiency in Data Management systems and processes through regular training
Performs other work-related duties as assigned

Qualification

Clinical Data ManagementRegulatory ComplianceProject ManagementFinancial ManagementTeam LeadershipProcess ImprovementCommunication SkillsMentoring

Required

Ensures project launch, conduct, and closeout activities are performed according to the Customer's and the Company's contractual agreement
Ensures that all project-related data management tasks are completed in accordance with internal and customer quality standards, Syneos Health SOPs, and all pertinent industry/regulatory guidelines and legal requirements from commencement to closure of a project
Ensures project documentation is filed on an ongoing basis and the TMF is maintained in an inspection ready state
Manages multiple projects ranging in size and complexity from single service studies, to multiple global projects within a program, with interaction from supervisor as required
May serve as the sponsor liaison
May proactively manage the scope, budget, and resource for their assigned projects under the guidance of an Associate Director/Director
Manages the financial aspects of the assigned projects, including ensuring projects maintain the correct level of gross profit, and changes in scope are applied as necessary
Ensures that customers are invoiced in a timely manner
Identify data management project issues and alert Manager (Senior Department Management) with a view to remedial action
May serve as point of escalation for individual projects
Ensure effective communication between departments and with Sponsor to ensure a high level of client satisfaction through successful execution of projects
May review Protocol, Data Management Plan, CRF and Edit Check Specifications to ensure consistency across documentation
Ensures a review of relevant project Data Management study files for currency and accuracy, including development of a corrective action plan for quality issues or non-compliance
Line Management and functional support of assigned staff
Interview, onboard and train new staff as appropriate
Oversee professional development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching
Mentors staff in general team leadership skills, project management skills, internal Company processes, and for project specific tasks
Manage the resources / workload of assigned team and projects, assigns tasks to team members, manage billable and non-billable time, and subsequently monitors productivity / utilization, timeliness, and quality
Maintains and evaluates project progress
May work with PDMs to prepare for and attend Project Review Meetings
May participate in Sponsor or regulatory audits
May represent Clinical Data Management at Business Development and Sponsor-related meetings with support from the Associate Director/Director
May perform training for data management staff to internal and external audiences as required
Maintains departmental resourcing tracking tools
May lead or participate in process improvement/departmental strategic initiatives to support the Business
This may include the development of departmental technologies, SOPs, processes and procedures
Maintains proficiency in Data Management systems and processes through regular training
Performs other work-related duties as assigned

Benefits

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture

Company

Syneos Health

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Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.

H1B Sponsorship

Syneos Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)

Funding

Current Stage
Public Company
Total Funding
$524.65M
2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M

Leadership Team

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Costa Panagos
Chief Executive Officer
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Michael Bonello
Executive Vice President and Chief Financial Officer
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Company data provided by crunchbase