Job Closed

This listing is no longer active.

Senior Manager, Clinical Data Management

ManagerManagerOtherRemoteSeniorTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

87 days ago

Salary

$175K - $192K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglishGCP

Job Description

Senior Manager, Clinical Data Management

Celcuity

• Report into the Executive Director, Clinical Data Management. • Focus on all aspects of the CDM process from project planning, development of project documentation, system set-up, UAT through database lock. • Responsible for timelines and quality of CDM deliverables for the assigned studies. • Contributes to technical infrastructure of CDM such as the development of SOPs, departmental process improvement etc. • Provides feedback and task assignment to meet department and company objectives. • Supports budget and resource planning across assigned projects as required. • Participates in CRO/vendor selection process for outsourced activities. • Directs activities of direct reports as applicable. • Represents CDM in study team meetings. • Manages CDM timelines to coordinate and synchronize deliverables with overall study timelines. • Generates and/or reviews/approves study documents (e.g. study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, coding conventions). • Oversight of CDM CRO/service providers (e.g. reviewing vendor SOPs, invoices). • Monitors the progress of all CDM activities for the project to ensure project timelines are met. • Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, and able to work independently towards the assigned goal.

Job Requirements

  • Bachelor’s or master’s degree (preferred) in Life Sciences, Computer Sciences, Mathematics, or health-related field.
  • Minimum ten (10) years of DM experience in the pharmaceutical or biotechnology industry.
  • Three (3) year of staff management desired.
  • Demonstrated ability to pay attention to details and superior organizational skills.
  • CRO management experience.
  • In-depth knowledge of CDM principles, clinical trial process and regulatory requirements.
  • Excellent verbal/written and interpersonal skills; able to communicate and collaborate effectively with cross-functional teams in a remote setting.
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
  • Proven ability to work both independently and in a team setting.
  • Experience with web-based Electronic Data Capture (EDC) preferably Medidata Rave, clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
  • Prior oncology/hematology experience highly desirable.
  • Ability to work in a team or independently as required.
  • Outstanding organizational skills with the ability to prioritize.
  • Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
  • Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
  • Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
  • Maintain a positive, approachable and professional attitude.

Benefits

  • Annual performance incentive bonus
  • New hire equity package
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • 401(k) match
  • Paid time off
  • Paid holidays

Related Categories

Related Job Pages

More Manager Jobs

OtherRemoteTeam 11-50H1B No Sponsor

• Facilitate screenings for interested individuals to determine appropriate fit for a virtual IOP experience. • Conduct biopsychosocial assessments and develop individualized recovery plans. • Coordinate with therapists, group facilitators, and medical providers to support integrated care. • Provide referrals to housing, employment assistance, legal services, educational resources, and community support. • Monitor and document client progress, engagement, and progress towards treatment goals. • Maintain timely and accurate documentation in Meridian’s identified electronic medical records platform. • Participate in multidisciplinary team meetings and collaborate on treatment/recovery planning. • Provide crisis intervention and support as needed, escalating appropriately. • Advocate for client needs and assist in removing barriers to recovery. • Ensure discharge planning is initiated early and includes comprehensive transition and aftercare coordination. • Stay informed on community resources, insurance coverage requirements, and evolving best practices in behavioral health.

California
$20 - $23 / hour
Job Closed

Home Health Quality Care Manager, RN

Mission Healthcare

Mission Healthcare is a healthcare organization delivering home-based services designed to support patients and providers through a new era of care. Guided by i

Manager87 days ago

• Coordinates and oversees all direct and indirect patient services provided by clinical organization personnel. • Provides guidance and counseling to coordinators and Clinical Supervisors/Nursing Supervisors to assist them in continually improving all aspects of home health care services, provided through organization personnel. • Assists Clinical Supervisors/Nursing Supervisors in managing clinical teams and planning. • Provides help in assessment, planning, implementation and evaluation of patient and family/caregiver care to all clinical personnel as indicated. • Assists the Executive Director/Administrator in the preparation and administration of the organization's budget. • Interprets operational indicators to detect census changes and increases or decreases in volume, which could impact staffing levels, revenues or expenses. • Evaluates performance of Clinical Supervisors/Nursing Supervisors. • Assists Clinical Supervisors/Nursing Supervisors to develop skills and techniques in evaluating the performance of clinicians. • Hires, evaluates, and terminates organization personnel. • Conducts clinical performance evaluations annually, or more frequently if indicated. • Oversees the maintenance of patient clinical records, statistics, reports and records for purposes of evaluation and reporting of organization activities. • Assures proper maintenance of clinical records in compliance with local, state and federal laws. • Responsible for the maintenance of adequate and appropriate inventory supplies and equipment for the provision of patient services. • Develops, implements and evaluates the orientation program for new organization personnel. Responsible for orientation of new organization personnel, either directly or by delegating to another staff member. • Plans and implements Inservice and continuing education programs to meet education and training needs of organization personnel. • Assists with the evaluation of organization performance via performance improvement program, productivity, quarterly and annual reviews. Assures for the quality and safe delivery of hospice services provided through the Organization. • Assists in the development of organization goals. Develops, recommends, and administers Organization policies and procedures.

United States
$85K - $95K / year
Job Closed
Campus Compact logo

Manager, Narrative & Storytelling

Campus Compact

Educating citizens, building communities.

Manager87 days ago
OtherRemoteTeam 11-50Since 1985H1B No Sponsor

• Contribute to Campus Compact communications strategy as chief storyteller • Oversee storytelling and narrative change work • Develop narrative change strategy and create key deliverables • Build public relations and media capacity • Supervise the digital communications coordinator

United States
$70K - $75K / year
Job Closed
Hairball logo

Project/Delivery Manager

Hairball

Hundreds of companies of all sizes partner with Hairball to automate, integrate, and transform their business.

Manager87 days ago
OtherRemoteTeam 11-50Since 2021

• Own end-to-end delivery of NetSuite and integration projects, from kickoff through go-live and post-go-live stabilization. • Act as the primary point of accountability for scope, timeline, risks, and delivery quality. • Build and manage project plans, timelines, dependencies, and milestones. • Lead customer meetings, drive decisions, and keep stakeholders aligned and moving forward. • Coordinate work across NetSuite consultants, integration engineers, and customer teams. • Ensure requirements are clearly defined, documented, and translated into executable plans. • Identify risks early and proactively manage scope, timeline, and resource tradeoffs. • Ensure proper testing, cutover planning, and go-live readiness. • Hold teams accountable to commitments while maintaining strong customer relationships. • Ensure projects follow Hairball delivery standards and best practices. • Support continuous improvement of project delivery processes and tooling.

United States