Study Manager Job

STUDY MANAGER needed for a CONTRACT opportunity with Yoh's client located in Research Triangle Park, NC.

TOP SKILLS SHOULD YOU POSSESS:

- Project Management
- Clinical operations

WHAT YOU'LL BE DOING:

- The Study Manager has responsibility for the overall conduct of the study, including, but not limited to, the tasks listed below.
- Study Management: Produce a Clinical Monitoring Plan including Monitoring Guidelines developed in accordance with SOPs.
- Identify potential monitors for review and selection of Lead CRA and monitoring team.
- Train Lead CRA, monitoring team and other project team members as needed.
- Track project milestones and activities using project tracking tools provided by client or by developing project tracking spreadsheets.
- Provide project updates as scheduled and manage regular communication with counterparts, Lead CRA and monitoring team in a timely and proactive manner.
- Participate in scheduled teleconferences, team meetings and other communications as needed (eg, site enrollment updates, regulatory document status, site issues).
- Manage hot line for study triage to resolve questions or problems that arise at the sites (eg, protocol exceptions, safety issues, clinical supplies and general questions).
- This hot line would not perform recruitment enhancement services via a call in center but the team could assist with subject recruitment strategies.
- Verify and authorize initiation of investigator payments.
- Participate in and lead the writing and review of protocols, protocol amendments and clinical study reports
- Study Start-up: Study Document Preparation and Filing.
- Create or revise the Investigators Brochure.
- Create and finalize the protocol and/or amendments with input from client.
- Prepare Investigator and Coordinator binder(s) [Study Reference Manual].
- Prepare instructions for the collection, reporting and management of Serious Adverse Events (SAEs).
- Set up and maintain Sponsors central study files.
- Site Identification: Qualification and Training
- Assist with site identification using client site lists as a starting point.
- Phone screen potential site using questionnaire developed by client or other questionnaire as appropriate.
- Conduct Prestudy Site Visits to determine qualifications of selected sites.
- Document Prestudy Visits.
- Assist with final site selection
- Approve regulatory documents for submission to Regulatory Affairs.
- Contracts and Budget: Negotiate contract revisions with site and submit proposed revisions to client for approval.
- Case Report Forms (CRFs): Develop content, review and/or approve CRFs, diaries and/or questionnaires prior to submission to chosen vendor for formatting and printing. Write instructions for completion of CRFs, diaries and/or questionnaires.
- Clinical Supplies: Prepare Pharmacy/Investigational Product binder.
- Track availability and authorize initial shipment of clinical supplies to sites. Select and/or manage interactive voice response system (IVRS). Prepare IVRS instruction manual. Order and ship other required items for study conduct (eg, infusion sets, thermometers). L
- Laboratory Issues: Select and/or manage central laboratory services.
- Clinical Operations: Manage other clinical research support personnel as required by the study, ie, Clinical Support Specialists (CSS) or administrative assistants.
- Retrieve CRFs from sites and submit to Data Management. Respond to queries from Data Management concerning AE and concomitant medication coding. Identify and log protocol deviations. Review study drug administration records. Perform drug reconciliation. Verify destruction of clinical supplies by site, reviewing procedures as needed. Verify site compliance with GCP regulations, including study file audit. Follow-up with sites to finalize SAE information. Manage/track shipment of laboratory kits and return of laboratory samples.
- Manage/track shipment of clinical supplies.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree
- Three (3) plus years clinical operations/study management experience

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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