Senior Clinical Data Manager/Principal Clinical Data Manager Remote, United States

5 days ago

Gisborne, Gisborne, New Zealand Tbwa ChiatDay Inc Full time

Senior Clinical Data Manager/Principal Clinical Data ManagerRemote, United States
*This position is 100% remote, but the preference is to have someone on the east coast* Position Summary:
The Senior Clinical Data Manager/Principal Clinical Data Manager is responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects.
Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study-specific plans and guidelines will be followed.
This position will also oversee and/or perform database development and testing.
Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.May perform quality control of data entry.Provide input, assess and manage timelines.
Ensure that clinical data management deadlines are met with quality.Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.May assist in building clinical databases.Conduct database build UAT and maintain quality controlled database build documentation.May specify requirements for all edit check types e.g.
electronic, manual data review, edit checks, etc.Responsible for creating, revising, appropriate versioning and maintaining data management documentation.Train clinical research personnel on the study-specific CRF, EDC, and other project-related items as needed.Review and query clinical trial data according to the Data Management Plan.Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM.Run patient and study level status and metric reporting.Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency.Liaise with third-party vendors such as external data and EDC vendors in a project-manager capacity.May assist with SAS programming and quality control of SAS programs used in the Data Management department.Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members.May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project.Participate in the development and maintenance of Standard Operating Procedures (SOPs) related to data management and database management activities.May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings.May review Request for Proposals (RFP), proposals, and provide project estimates.Provide leadership for cross-functional and organization-wide initiatives, where applicable.Train and ensure that all data management project team members have been sufficiently trained.Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues.May present software demonstrations/trainings, department/company training sessions, present at project meetings.May require some travel.Perform other duties as assigned.Qualifications:
Minimum Required:
Bachelors and/or a combination of related experience.Other Required:
8+ years' experience for a Sr. Clinical Data Manager and 10+ years for a Principal Clinical Data Manager.Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.Able to handle a variety of clinical research tasks.Excellent organizational and communication skills.Professional use of the English language; both written and oral.Experience in utilizing various clinical database management systems.Broad knowledge of drug, device and/or biologic development and effective data management practices.Strong representational skills, ability to communicate effectively orally and in writing.Strong leadership and interpersonal skills.Ability to undertake occasional travel.Preferred:
Experience in a clinical, scientific or healthcare discipline.Dictionary medical coding (MedDRA and WHODrug).Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.
).Oncology and/or Orphan Drug therapeutic experience.Compensation:
Reasonable estimate of the current range: $113,000 - $180,000 USD.
This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, you may contact Precision Medicine Group at ******.

#J-18808-Ljbffr

  • Principal Clinical Data Manager Position

    1 day ago

    Gisborne, Gisborne, New Zealand Tbwa ChiatDay Inc Full time

    Job DescriptionWe are seeking an experienced Senior Clinical Data Manager/Principal Clinical Data Manager to join our team. As a key member of our data management department, you will be responsible for managing all aspects of clinical trial data management.Your primary responsibilities will include managing study start-up to post-database lock for assigned...

  • Clinical Data Management Lead

    1 day ago

    Gisborne, Gisborne, New Zealand Tbwa ChiatDay Inc Full time

    Clinical Data Management OpportunityWe are currently seeking an experienced Senior Clinical Data Manager/Principal Clinical Data Manager to join our team. As a key member of our data management department, you will be responsible for managing all aspects of clinical trial data management.This includes managing study start-up to post-database lock for...

  • Clinical Data Management Lead

    7 days ago

    Gisborne, Gisborne, New Zealand Tbwa ChiatDay Inc Full time

    **Job Summary:**We are seeking a highly skilled and experienced Clinical Data Management Lead to join our team at Tbwa Chiat/Day Inc. As a key member of our data management team, you will be responsible for overseeing all aspects of the clinical trial data management process from study start-up to post-database lock.The ideal candidate will have a strong...

  • Data Manager Senior Specialist

    7 days ago

    Gisborne, Gisborne, New Zealand Tbwa ChiatDay Inc Full time

    **About the Role:**Tbwa Chiat/Day Inc is seeking a seasoned Principal Clinical Trial Manager to lead our data management efforts. As a key member of our team, you will be responsible for overseeing all aspects of the clinical trial data management process, from study start-up to post-database lock.The ideal candidate will have a strong background in clinical...

  • Principal Clinical Trial Manager

    7 days ago

    Gisborne, Gisborne, New Zealand Tbwa ChiatDay Inc Full time

    **Job Overview:**We are seeking a highly skilled and experienced Senior Data Operations Manager to join our team at Tbwa Chiat/Day Inc. As a key member of our data management team, you will be responsible for overseeing all aspects of the clinical trial data management process from study start-up to post-database lock.The ideal candidate will have a strong...

  • Senior Data Operations Manager

    7 days ago

    Gisborne, Gisborne, New Zealand Tbwa ChiatDay Inc Full time

    **About the Position:**Tbwa Chiat/Day Inc is seeking a skilled Clinical Data Management Specialist to lead our data management efforts. As a key member of our team, you will be responsible for overseeing all aspects of the clinical trial data management process, from study start-up to post-database lock.The ideal candidate will have a strong background in...

  • Clinical Trials Operations Manager

    5 days ago

    Gisborne, Gisborne, New Zealand Gateway Recruiting Full time

    About the Position: As a key member of our team, the Clinical Trials Operations Manager will oversee the day-to-day activities of clinical trials. Based in the US, preferably on the East Coast, this professional will report directly to the company VP R&D.Main Responsibilities: Key tasks include managing site installations, providing case support, overseeing...

  • Clinical Operations Manager

    7 days ago

    Gisborne, Gisborne, New Zealand Tbwa ChiatDay Inc Full time

    About UsForge Health is a pioneering outpatient mental health and substance use provider dedicated to delivering exceptional, affordable, and evidence-based care to individuals, families, and communities in need. With a proven track record of driving clinical outcomes, Forge Health is at the forefront of innovation, improving care delivery, and shaping the...

  • Senior Clinical Trials Manager

    10 hours ago

    Gisborne, Gisborne, New Zealand Compass Pathways Full time

    About the Role: We are seeking an experienced Clinical Operations professional to join our team as Associate Director, Clinical Trial Delivery. In this role, you will be responsible for overseeing the operational execution of clinical trials, ensuring adherence to timelines, budget, and quality standards.Duties and Responsibilities:Oversee the day-to-day...

  • Associate Director, Clinical Trial Delivery

    18 hours ago

    Gisborne, Gisborne, New Zealand Compass Pathways Full time

    Job Overview: The Associate Director, Clinical Operations plays a key role in the execution of clinical trials, ensuring operational excellence and the successful delivery.This position involves overseeing the day-to-day management of clinical trials, collaborating closely with cross-functional teams, and ensuring adherence to the highest standards of...

  • Field Clinical Engineer

    6 days ago

    Gisborne, Gisborne, New Zealand Gateway Recruiting Full time

    Job Description:The Field Clinical Engineer (FCE) located in the US (preferably on the East Coast) will report to the company VP R&D.The FCE will be responsible for supporting clinical sites and will be the primary point of contact for the sites' clinical team.Main Responsibilities:Supporting clinical trials: site installation, case support, EDC etc.Manage...

  • Clinical Affairs Specialist

    2 days ago

    Gisborne, Gisborne, New Zealand Gateway Recruiting Full time

    Job OverviewAt Gateway Recruiting, we are seeking a highly skilled Field Clinical Engineer to join our team. This exciting role will involve supporting clinical sites and serving as the primary point of contact for the sites' clinical team.Main ResponsibilitiesSupporting clinical trials: site installation, case support, EDC etc.Manage and provide...

  • Senior Director, Business Development

    1 week ago

    Gisborne, Gisborne, New Zealand Saama Technologies, Inc. Full time

    Senior Director, Business DevelopmentWork Location – Home (Remote) East Coast Based.Saama (A Carlyle Portfolio Company) focuses on the specific needs of pharmaceutical & biotech companies, delivering transformative business outcomes.The combination of Saama's AI research, advanced technical & analytics capabilities, domain expertise across the drug...

  • Senior Pharmacist Clinical Lead Role

    7 days ago

    Gisborne, Gisborne, New Zealand Waitemata District Health Board Full time

    **About the Role**This senior pharmacist position provides a unique opportunity to make a positive difference by leading our clinical pharmacy team. The successful candidate will have the drive and passion to provide strategic direction and clinical supervision.The Clinical Pharmacy Team Lead coordinates closely with the Chief Pharmacist and Pharmacy Manager...

  • Director, Business Development New Remote, United States

    3 weeks ago

    Gisborne, Gisborne, New Zealand Tbwa ChiatDay Inc Full time

    This position is a remote role; however, we need someone located on the East CoastThis role has a robust commission plan with our base salaryPosition Summary:The Director, Business Development is responsible for identifying and closing significant business opportunities for Precision Bioservices in the assigned area of responsibility and/or region.Essential...

  • Senior Director, Business Development

    3 weeks ago

    Gisborne, Gisborne, New Zealand Saama Technologies, Inc. Full time

    Senior Director, Business Development Work Location – Home (Remote) East Coast Based.Saama (A Carlyle Portfolio Company) focuses on the specific needs of pharmaceutical & biotech companies, delivering transformative business outcomes.The combination of Saama's AI research, advanced technical & analytics capabilities, domain expertise across the drug...

  • Clinical Therapist

    7 days ago

    Gisborne, Gisborne, New Zealand Geneva Staffing Full time

    About the RoleWe are seeking a skilled Hand Therapist to join our team at Geneva Staffing. As a Clinic-Based Hand Therapist, you will manage a caseload of musculoskeletal and orthopedic patients, delivering high-quality, person-centered care.Working in a well-equipped clinic, you will provide treatment and rehabilitation in a supportive and collaborative...

  • Clinical Operations Director

    14 hours ago

    Gisborne, Gisborne, New Zealand Compass Pathways Full time

    Job Overview: The Associate Director, Clinical Trial Delivery plays a pivotal role in the execution of clinical trials, ensuring operational excellence and successful delivery. This position involves overseeing the day-to-day management of clinical trials, collaborating closely with cross-functional teams, and ensuring adherence to the highest standards of...

  • Clinical Pharmacy Team Leader

    1 week ago

    Gisborne, Gisborne, New Zealand Waitemata District Health Board Full time

    Job Description - Clinical Pharmacy Team Leader (HAU01531) Vacancy No:HAU01531Te whiwhinga mahi | The Opportunity We're looking for a senior pharmacist who has the drive and passion to make a positive difference by providing strategic direction and clinical supervision to our clinical pharmacy team.The Clinical Pharmacy Team Lead provides professional and...

  • Strategic Direction for Clinical Pharmacy Services

    7 days ago

    Gisborne, Gisborne, New Zealand Waitemata District Health Board Full time

    **Leadership Opportunity**This senior pharmacist position offers a unique opportunity to lead our clinical pharmacy team and contribute to improving patient outcomes. The successful candidate will have the ability to work collaboratively with other healthcare professionals and provide strategic direction and clinical supervision.Main Responsibilities:Develop...