Clinical Data Manager

The Resume Database; United States; Vor Ort; USD 69.000 - 110.000; Teilzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid parental leave

Vacation & holidays

Zusammenfassung

Penumbra, Inc. seeks a temporary Clinical Data Manager to lead data management for one or more clinical projects. The role focuses on ensuring data quality and integrity throughout startup, conduct, and closeout, while coordinating with cross-functional teams.

The position is 20 hours per week for an initial 6-month assignment, with potential extension. Candidates must be eligible to work in the United States and onsite work is required.

Qualifikationen

• Minimum education: Bachelor's degree with 5+ years in a medical device, pharma, CRO, or equivalent.
• Preferred: Master's degree with 3+ years in clinical research; CCDM certification a plus.
• Experience with electronic data capture systems (e.g., Medidata Rave, InForm, eClinicalOS, REDCap).

Aufgaben

• Lead data management activities within an assigned study, including startup, conduct, closeout, and reporting.
• Serve as DM SME on multidisciplinary teams and develop timelines and data deliverables.
• Oversee DM CROs and vendors for compliance with protocol, GCP, and regulatory standards.
• Maintain DM documentation per QMS and regulatory requirements.
• Provide DM training to CRAs and other teams; ensure data quality and integrity.

Kenntnisse

Clinical data management

GCP/regulatory knowledge

Vendor management

Team collaboration

MS Word/Excel/PowerPoint

Ausbildung

Bachelor's degree + 5+ years

Master's degree (preferred)

Tools

iMedidata Rave

InForm

eClinicalOS

REDCap

Jobbeschreibung

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
• Ability to effectively manage change and multiple priorities
• Ability to operate independently and achieve results; ability to effectively deal with employees and business contacts and conveys a positive service-oriented attitude
• Knowledge of continuous improvement, project management, change management, and risk management
• Medical device, pharmaceutical, biotech, or other regulated industry experience required
• Proficiency with MS Word, Excel, and PowerPoint

Working Conditions

• General office environment
• Willingness and ability to work on site.
• May have business travel from 0% - 5% to conferences and/or other Penumbra affiliated facilities.
• Potential exposure to blood-borne pathogens
• Requires some lifting and moving of up to 25 pounds
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Base Pay Range Per Hour

$50.00 - $80.00

Individual compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

What We Offer

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.