DurhamRecruiter Since 2001
the smart solution for Durham jobs

Clinical Operations Manager

Company: Brii Biosciences
Location: Durham
Posted on: February 24, 2021

Job Description:

SUMMARY: Drives the Clinical Project strategy and deliverables by providing expert operational oversight and guidance on multiple clinical studies (phase I through IV) through day-to-day CRO and vendor management, review and monitoring of work performed, metric compliance, and development of contingency plans as needed.
DUTIES AND RESPONSIBILITIES Objectives: Understands the overall Clinical Development plan for the asset and how the study(ies) fit within the corporate objectives. Executes clinical studies by leading study operational strategy and planning in addition to overseeing execution of clinical studies.-- Oversees the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations, and Brii Biosciences SOPs), within timelines and on budget.-- Oversees CROs and other 3rd party vendors to meet Brii Biosciences obligations and business objectives and as described in ICH-GCP.--- Challenge study team to ensure timelines meet the needs of the clinical development plan-- Responsible for study budget planning and management and accountable for external spend related to study execution. -- Works closely with Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate-- Communicates study status, cost, and issues to Brii Program Lead-- Serves as an escalation point for CROs and third-party vendors managed by CROs-- Maybe responsible for one or more studies of varying complexity.-- Participates in the selection of study CRO and vendors for assigned studies-- Performs oversite monitoring visits as required to ensure ICH-GCP and protocol compliance.-- Manages study operational plan and CRO activities, including project timelines & quality of deliverables, and preparing and managing approved trial budget(s), out of scope activities throughout the life of the assigned clinical trial(s)-- Maintains frequent and meaningful contact with CROs and vendors to optimize performance and provide guidance as needed to ensure study milestones are being met.-- Contributes to the development and maintenance of cross-functional plans to ensure study specific endpoints and regulatory goals are met. -- Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials for timely execution and to meet submission goals-- Contributes to relevant study documentation including clinical protocols, statistical analysis plan, clinical study reports as well as operational plans-- Assists with protocol design and medical issue resolution-- Proactively identifies project risks and resolves with some supervision-- Participates in study data review and other review activities as assigned-- Oversees the submission of trial-related and essential documents to the Trial Master File-- Identifies and provides solutions to clinical trial issues and/or risks-- Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated-- Coordinate, provide and/or facilitate operational and therapeutic area training to internal and external clinical study team members-- Work closely cross functionally to monitor quality, timelines and timely regulatory submissions-- Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested-- Mentors junior team members on clinical operations tasksQUALIFICATIONS:-- BS or Master's Degree in nursing, life science, or related field (or equivalent experience) -- Minimum of five years clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company including some time in a leadership capacity.-- Must have knowledge of clinical protocol and drug development processes with proven study planning and management skills-- Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirements -- Excellent communication, presentation, interpersonal, and change management skills, both written and spoken, with an ability to inform, influence, convince, and persuade -- Strong time management, technical and organizational skills. Ability to work independently and within a team environment. -- Knowledge of basic financial concepts as related to forecasting and budgeting. Understands project budgets. -- Must demonstrate good computer skills with high level proficiency with MS Office applications (e.g., Word, PowerPoint, XL, Project) and be able to embrace new technologies

Keywords: Brii Biosciences, Durham , Clinical Operations Manager, Executive , Durham, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Project Manager - Education/Healthcare Construction
Description: MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an (more...)
Company: Michael Page
Location: Raleigh
Posted on: 02/27/2021

Food Service Operations Manager Louisburg, NC (8947)
Description: Overview: You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...)
Company: Crum Pizza dba Domino's Pizza
Location: Castalia
Posted on: 02/27/2021

Physician Clinic Medical Director Raleigh, NC
Description: Overview More time for your patients and more time for you. It's time to learn more about careers at Concentra. At Concentra, our physicians spend 90 of their time clinically treating patients the remaining (more...)
Company: Concentra
Location: Raleigh
Posted on: 02/27/2021

Director, Finance
Description: Category Finance Actuarial Location Raleigh, North Carolina, US Full-time Job Id 1211888 WellCare of North Carolina Position Purpose: Manage the monthly, quarterly and annual budgeting process for (more...)
Company: Centene Corporation
Location: Raleigh
Posted on: 02/27/2021

Business Development Manager
Description: THIS ROLE CAN BE BASED ANYWHERE IN THE US BUT WITHIN CLOSE PROXIMITY TO AN AIRPORT. Adecco Search is recruiting on behalf of its client for the role of Business Development Manager where you will be responsible (more...)
Company: Adecco USA
Location: Raleigh
Posted on: 02/27/2021

Director, Pharmacovigilance/Drug Safety (Marketed Products) - NC Pharma/Remote Option
Description: Our client, a successful and expanding specialty pharmaceutical company headquartered in Research Triangle Park, NC, is actively recruiting for a highly skilled and knowledgeable candidate to drive all (more...)
Company: Frankel Staffing Partners
Location: Raleigh
Posted on: 02/27/2021

Senior Director, Engineering
Description: We're on a mission to protect digital communications to ensure humanity prevails over evil. Agari is transforming the email security landscape with the next-generation Secure Email Cloud--- powered by (more...)
Company: Agari Data Inc
Location: Raleigh
Posted on: 02/27/2021

Director, Digital Success
Description: Conga is seeking a Director, Digital Customer Success to lead the design and delivery of scalable, sustainable and effortless experiences across the customer journey. This role reports into the Global (more...)
Company: Apttus
Location: Raleigh
Posted on: 02/27/2021

Senior Sales Director - Payor Solutions (Remote)
Description: Senior Sales Director - Payor Solutions Remote Go-To-Market GTM - Strategic Alliances / Grand Rounds is a new kind of healthcare company. Founded in 2011, the company is on a mission to raise the (more...)
Company: Roman Health Pharmacy LLC
Location: Raleigh
Posted on: 02/27/2021

11B Infantryman - Management Training
Description: The Infantry is the backbone of the Army. These Soldiers fill the literal boots on the ground who are responsible for taking or holding ground during any combat operation. You'll attack, repel, and capture (more...)
Company: Army National Guard
Location: Smithfield
Posted on: 02/27/2021

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Durham RSS job feeds