Senior Project Manager, eSolutions (DCT) (Remote)
- Job Title
- Senior Project Manager, eSolutions (DCT) (Remote)
- Job ID
- 27631814
- Work From Home
- Yes
- Location
- Austin, TX 78738
- Other Location
- Description
-
JOB SUMMARY
Senior Project Management Specialist is member of our eSolutions/ Decentralized Clinical Trials (DCT) group. This position supports Elligo eSolutions projects by reviewing and verifying data across trial operations and vendors, along with providing general support to the eSolutions Central Management Office. Candidates must demonstrate the ability to understand the clinical research protocol and support its multiple, ongoing control operations to ensure efficient execution of project activities, data workflows, medical records management, and regulatory documentation in a central capacity.
Essential Duties & Responsibilities:
- Operationalizes eSolutions activities across various control teams according to study protocol and Good Clinical Practice. Specific tasks may include:
- Provide surveillance and quality check of data channels required for protocol execution which may include some of the following:
- Laboratory collections
- Clinical Imaging and/or ECGs
- Investigational Product
- In person or telemedicine visits conducted by Sub-Investigators
- Other study assessments, including clinician or patient reported outcomes questionnaires and assessments
- All patient and vendor data entered in IntElligo eSource
- Liaise with Patient Concierge team as needed to ensure optimal patient support and compliance throughout trial participation
- Perform data entry into sponsor EDC system
- Understands regulatory requirements of the central site and ensures archival of required documents is completed by regulatory team
- Confirms all patient records in IntElligo are present and ready for Quality Control (QC).
- Performs QC of documentation, under supervision of Elligo Central Office Manager and Central Principal Investigator
- Communicates record readiness to Elligo Central Office Manager and Central Principal Investigator
- Provide surveillance and quality check of data channels required for protocol execution which may include some of the following:
- Maintains the integrity of IntElligo, the eSource/study database, which includes:
- Tracking progress and timeliness
- Maintaining the status of all subject’s medical records in the database
- Adherence to IRB approved protocol
- Generates weekly reports for both internal and external teams, as assigned.
- Establishes rapport, ensuring courteous and efficient service to all stakeholders, (i.e., Sponsor, partner organizations, study participants, Elligo colleagues, local sites).
- Maintains confidentiality, prioritizes, and manages work effectively, and provides exceptional customer service.
- Demonstrates knowledge of the Company’s clinical research studies as well as the diagnoses and medical terminology that is involved in the study. Responsible for understanding the protocol, inclusion/exclusion criteria and a comprehensive understanding of trial being conducted.
- Performs other duties not specifically listed in this job description as assigned by immediate supervisor.
- May assist Central Project Manager by collaborating with finance to coordinate payment to patients or Sub-I’s
- May assist/mentor less experienced peers.
Qualifications:
- Experience working with EMR’s, CTMS, EDC, or similar systems preferred
- BS/BA degree and a minimum of 3 years of experience in a healthcare setting, or an equivalent combination of education and experience, is required. Clinical research or clinical trial vendor experience strongly preferred. Data entry experience is preferred
- Thorough understanding of Good Clinical Practices
- Thorough understanding of HIPAA privacy and security laws around PHI.
- Clinical research experience strongly preferred. Data entry experience is preferred
- Quick learner and resourceful, able to quickly learn a new system and understand the patient and clinical data’s journey throughout a trial.
- Strong verbal and written skills
- Attention to detail
- Team player
- Proficiency with word processing, spreadsheet, database software (MS Office skills such as Word, Outlook, Excel, PowerPoint, SharePoint)
- Legally authorized to work in the United States for any employer without sponsorship.
About Elligo Health Research:
Elligo helps speed new therapies to market by enabling large numbers of patients and clinicians to participate in clinical research. Studies have shown that only a very small portion of eligible patients participate in clinical research, even though a majority say they are interested in doing so. We remove the logistical obstacles that prevent their participation. Our unique direct to patient model allows us to streamline patient identification and qualification, site activation, patient enrollment, study initiation and study conclusion. This results in more efficient and cost-effective trials and acceleration of new therapies to market. www.elligodirect.com
- Operationalizes eSolutions activities across various control teams according to study protocol and Good Clinical Practice. Specific tasks may include: