Clinical Data Manager

pofft Technology Inc.; États-Unis; À distance; USD 39 000 - 55 000; Temps partiel

Résumé du poste

Penumbra is seeking a temporary Clinical Data Manager to lead data management activities for one or more clinical studies. The role supports trial teams remotely from a US home office and requires 20 hours per week with an initial 6-month assignment that may be extended.

Applicants must be eligible to live and work in the United States. The ideal candidate brings 5+ years in medical device/pharma DM, strong EDM experience (Rave/InForm/eClinicalOS/REDCap), and a track record of regulatory

Qualifications

• Bachelor's degree with 5+ years in a medical device, pharmaceutical company, or similar environment (e.g., CRO)
• Master’s degree with 3+ years of clinical research preferred
• CCD M certified preferred
• Experience with electronic data capture systems (Rave, InForm, eClinicalOS, RedCap) is required
• Regulatory trial experience in medical device/pharma environment preferred

Responsabilités

• Lead data management activities within assigned study, from startup to closeout
• Serve as data management SME on cross-functional project teams
• Create and monitor project timelines and DM deliverables
• Oversee DM CROs and other vendors for compliance with SOPs and GCPs
• Ensure DM documentation is filed according to regulatory requirements
• Coordinate with DM, biostatistics, Clinical Affairs and Medical Affairs teams to ensure data integrity
• Provide DM training and SOP/process improvements
• Participate in audits and inspections
• Train CRAs to ensure consistent data entry at sites
• Adhere to QMS and regulatory standards

Connaissances

exec sys admin

infosec

education

technical

customer support

travel

excel

sales

biotech

medical

Formation

Bachelor's degree

Master’s degree

Outils

iMedidata Rave

InForm

eClinicalOS

RedCap

Description du poste

Clinical Data Manager Your Remote US Home Office 2 gün 21 saat 48 dakika önce yayınlandı. RemoteOK -

General Summary
The temporary Clinical Data Manager acts as a lead data manager for one or more projects, applies data management experience to clinical trials, and utilizes functional knowledge of the logistics of clinical trials to ensure the quality and integrity of clinical trial data. The CDM works on multi-functional teams and supports clinical trial projects as a departmental subject matter expert (SME).

We are seeking a temporary clinical data manager who can dedicate 20 hours a week to support ongoing study activities. The initial assignment is for 6 months, but may be extended to meet the needs of our Team. Applicants must be eligible to live and work in the US.

Specific Duties and Responsibilities

• Independently lead and/or perform all data management activities within an assigned study (e.g., study startup, study conduct, study closeout, and reporting). *
• Serve as the data management SME on multidisciplinary project teams providing specific expertise on timeline development, identification of data management deliverables and resource requirements. *
• Participate in the creation, review, and maintenance of project timelines and monitor progress of data management activities. *
• Provide oversight for Data Management CRO and other vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, and other relevant guidelines.
• Ensure Data Management documentation is filed/archived according to applicable Penumbra and regulatory requirements. *
• Interact with data management, biostatistics, Clinical Affairs and Medical Affairs team to ensure integrity and quality of data. *
• Contribute ideas to the development of the department, identifying areas for improvement (e.g., SOPs, processes)
• Participates in audits and inspections. *
• Attend Investigator Meetings when requested to provide training on CRF data completion.
• Responsible for creation of training materials and training of the CRAs to ensure consistency of data entry at the sites. *
• Provide DM departmental training and to other teams, as needed.
• Utilizes reports to track study progress and ensure timeliness and quality expectations are met.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
• Perform other work-related duties as assigned.

*Indicates an essential function of the role

Required Qualifications

Minimum education and experience

• Bachelor's degree with 5+ years in a medical device, pharmaceutical company, or similar environment (e.g., CRO); or an equivalent combination of education and experience

Preferred qualifications

• Master’s degree with 3+ years of clinical research, pharmaceutical company preferred
• Thorough knowledge of effective clinical data management practices; CCDM certified professional a plus
• Must have strong experience with systems used for electronic capture of clinical trial data (e.g., iMedidata Rave, InForm, eClinicalOS, RedCap)
• This position must have experience working on regulatory trials within the medical device and/or pharmaceutical industry
• Position requires technical, organizational, analytical, and strong communication skills
• Knowledge of regulatory guidelines pertaining to data quality and data management
• Proven experience and in-depth understanding of all aspects of Data Management

...

Skills

exec sys admin infosec education technical customer support travel excel sales biotech medical

Payment Type

-

Price Range

-

Work Type

-

Location

Your Remote US Home Office

Source

RemoteOK