Clinical Outcomes Director jobs in Bridgeport, CT
Clinical Outcomes Director directs in-depth analysis of clinical outcomes data to develop clinical process improvement initiatives. Oversees and leads staff who gather data on performance metrics and facilitates the review of clinical program effectiveness. Being a Clinical Outcomes Director creates, defines, and implements performance metrics to review program effectiveness. Evaluates patient data to ensure that care is provided in accordance with clinical guidelines and organizational standards. Additionally, Clinical Outcomes Director identifies opportunities and provides recommendations to improve program delivery, patient outcomes, and operational efficiency. Requires a bachelor's degree in nursing or healthcare related area. May require a Registered Nurse (RN) license. Typically reports to senior management. The Clinical Outcomes Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. To be a Clinical Outcomes Director typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. (Copyright 2024 Salary.com)
Recently Added Clinical Outcomes Director jobs
Director, Clinical Operations
- Bausch + Lomb
-
Southport, CT
FULL_TIME
-
Bausch Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Position Summary :
Is responsible for the implementation and oversight of clinical study operations by organizing and coordinating with other relevant parties the planning, implementation, management, execution and completion of clinical studies according to applicable regulations and guidance, ICH and GCP, and Bausch & Lomb SOPs within agreed-upon timeframes and budget. Also responsible for effective communication within the corporation (and with external entities, where appropriate) of the issues and actions related to the successful completion of these studies. May serve as the primary project team representative for Clinical Operations.
Major areas of Responsibility :
Clinical Operations:
Manage and/or oversee the development process for critical study documents (e.g., protocol, amendments, IB, ICF, and CRFs). Will also work closely with members of other functional areas to provide input on study-related documents and issues (DMP, SAP, drug/device supplies, CSR, etc.).
Provides clinical operations input in the identification, evaluation, and selection of CROs and vendors (e.g., central labs, central IRB, IVRS, etc.).
Manage the identification, evaluation, and selection of investigators/sites.
Ongoing assessment, evaluation and management of internal and external resources.
Ensure study supply requirements are met.
Responsible for the appropriate communication with and maintenance of clinical study sites including training of site personnel in the study protocol and other study-specific procedures.
Supervise clinical operations team to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and B&L SOPs.
Communicate with relevant global team members, other B&L departments (e.g., R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilence/GPSS and Drug/Device Safety, and Clinical Supplies), and external consultants to ensure study objectives are being met and provide the operations director and/or senior management with timely updates on progress and changes in scope, schedule, and resources.
Organize investigator and expert meetings relevant to the indication and assist with the organization and management of DSMBs and Data Review Committees, as necessary.
Prepare study timelines and budgets and ensuring study execution is aligned with these targets.
Supervise clinical staff and vendors to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and B&L SOPs.
Responsible for the quality of all study-related documentation (e.g., Trial Master File, site qualification and initiation visits reports, interim monitoring visit reports, clinical monitoring plan, informed consents, CRF completion guidelines, pharmacy manual, etc.) during study start-up and throughout the life of the project to ensure that procedures are followed in an appropriate and consistent manner.
Oversee the preparation of procedures for the conduct and monitoring of clinical research such as Clinical Monitoring Plans, procedures for reporting of adverse events, CRF completion guidelines, Study Manual, etc.
Liaise with PVG/GPSS and provide clinical operations support and guidance for the ongoing surveillance of the safety of patients in clinical trials by reviewing reported AEs and SAEs and assure proper reporting of the events to the IRBs/REBs/ECs.
Liaise with Data Management to review data discrepancies and ensure that data clarification forms (queries) are appropriately handled by the CRAs and responded to by the site/investigator in a timely manner. May assist in the review of queries to determine criticality of the DCF during data clean-up and lock process.
Liaise with vendors and study site personnel and clinical investigators to provide study related guidance and answers to operational issues.
Budgets and Forecasts:
Provide input to Finance to forecast study expenditures and resourcing needs.
Review RFPs and proposals from external vendors.
Ensure subordinates and vendors manage and monitor study related expenses to meet forecast.
Regulatory Reports:
Provide Clinical Operations support in the timely coordination and execution of clinical study reports.
Assist in the review of regulatory reports to ensure that reports accurately reflect proper interpretation of the clinical study findings.
Assist to ensure annual IND/IDE and IB/ROPI updates are completed in an accurate and timely manner.
Provide Clinical Operations support to the Regulatory Affairs department.
Leadership:
Manage in-house team of CRAs, CTAs and/or CTMs for one or more studies to ensure execution of all studies in a timely and efficient manner.
Provide leadership, training, and development support to the study team.
May lead meetings (face-to-face, teleconferences, etc.) with external vendors ensuring problems are identified and issues are resolved quickly and efficiently.
May serve as a representative on internal committees/teams for Clinical Operations or cross-functional activities.
Foster a dynamic, matrixed working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging study team members to meet and/or exceed expectations.
Encourage professional growth of personnel through regular training sessions, and by acting as a resource to clinical staff. May lead training sessions.
Provide guidance and comments on SOPs revisions. May act as a leader of a SOP sub-committee for SOP revisions.
May visit sites with CRAs as needed to provide hands-on training as well as to discuss study related issues and problems with the Principal Investigator and/or site staff.
Share/present knowledge and information with appropriate departmental, project, or study team members for training purposes.
POSITION REQUIREMENTS :
Strong knowledge of Good Clinical Practices (GCP), clinical trials management (including site monitoring), scientific methods, research design, regulatory compliance, and clinical data management.
Minimum 10-12 years experience in the industry with a minimum of 6 years of managing clinical trials.
Minimum of 5 – 6 years experience in managing and training clinical personnel (Executive CRAs, CRAs, project assistants).
Strong planning and organizational skills with ability to multi-task and plan activities as it relates to management of clinical trials.
Experience leading and working within cross-functional teams.
Experience in managing CROs and external vendors.
Excellent written and verbal communication skills and strong interpersonal skills in order to interface with physicians, outside vendors, consultants, team members and various audiences.
Ability to problem solve, build teams, and to lead and motivate others.
Effectively work independently as well as within a team matrix.
Financial management skills as applicable to overseeing project expenditures and forecasts.
Advanced computer skills (Microsoft applications, spreadsheets and data displays, etc.)
Willing and able to travel.
Colorado
As required by Colorado’s Salary Transparency Law, Bausch Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in Colorado. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For Colorado, the range of starting annual base pay for this role is $180,00 - $200,000.
New York City
As required by New York City’s salary transparency provisions of the New York City Human Rights Law, Bausch Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in New York City. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For New York City, the range of starting annual base pay for this role is $180,00 - $200,000.
California
As required by California's Salary Transparency Law, Bausch Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in California. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For California, the range of starting annual base pay for this role is $180,00 - $200,000.
Washington
As required by Washington's Salary Transparency Law, Bausch Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in Washington. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For Washington, the range of starting annual base pay for this role is $180,00 - $200,000.
New York State
As required by New York State's pay transparency bill, Bausch Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in New York State. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For New York State, the range of starting annual base pay for this role is $180,00 - $200,000.
This position may be available in the following location(s): [[location_obj]]
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
Our Benefit Programs: https://www.bausch.com/careers/benefits/
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. - 1 Month Ago
Director, Clinical Operations
- Bausch + Lomb
-
Fairfield, CT
FULL_TIME
- Bausch Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through ever...
- 1 Month Ago
Clinical Director - BCBA
- Helping Hands Family
-
Shelton, CT
FULL_TIME
- Overview Work at a top-rated ABA provider managed by a clinical leadership team of BCBAs! Helping Hands Family (HHF) provides ABA services in our clinics, in family homes, and in the community. Our mi...
- 25 Days Ago
Clinical Director - Board Certified Behavior Analyst (BCBA)
- ABA Achievements
-
Fairfield, CT
PART_TIME
- ABA ACHIEVEMENTS is seeking a Board Certified Behavior Analyst (BCBA) to serve as our Clinical Director. Join us as we strive to enhance the standard of clinical excellence in ABA services. About ABA ...
- 26 Days Ago
Med/Surg Staff Nurse (nights)
- Clinical Management Consultants
-
Trumbull, CT
FULL_TIME
- Join A Dynamic Team as a Medical/Surgical RN (Nights) at a Premier Acute Care Facility near the Southern Coast of Connecticut! Are you a compassionate and skilled Registered Nurse with a passion for m...
- 15 Days Ago
Emergency Department RN Supervisor
- Clinical Management Consultants
-
Trumbull, CT
FULL_TIME
- Are you ready to take the lead in a dynamic Emergency Department setting? A highly reputable 150 bed acute care hospital in Southern Connecticut, is seeking an enthusiastic and experienced Emergency D...
- 15 Days Ago
Filters
- Current Active Filter
- Bridgeport, CT
Clear All
- Filter Jobs By posted time
- Within 1 Day
- Within 2-7
- Within 1 Month
- Within 3 Months
0 Clinical Outcomes Director jobs found in Bridgeport, CT area
Occupational Therapist ~ Pediatrics ~ Outpatient clinic and/or Schools
- CENTER FOR PEDIATRIC THERAPY F
-
Fairfield, CT
- Job Description Job Description THE CENTER FOR PEDIATRIC THERAPY seeks enthusiastic Occupational Therapists to join our ...
- 4/24/2024 12:00:00 AM
Speech Language Pathologist~ CFs~ School/Clinic Opportunities
- CENTER FOR PEDIATRIC THERAPY F
-
Fairfield, CT
- Job Description Job Description THE CENTER FOR PEDIATRIC THERAPY seeks enthusiastic Speech Language Pathologists (CCC-SL...
- 4/24/2024 12:00:00 AM
Clinic Director
- Ellie Mental Health - 241
-
Larchmont, NY
- Job Description Job Description As a Clinic Director at Ellie Mental Health - Lower Westchester, NY you'll share our vis...
- 4/23/2024 12:00:00 AM
Clinical Director of Quality, Saint Joseph's Medical Center, Yonkers NY
- St. Vincent's Hospital Westchester
-
Yonkers, NY
- Job Description Saint Joseph's Medical Center is seeking a full time Clinical Director of Quality under the direction of...
- 4/22/2024 12:00:00 AM
Practice Manager
- Artistry Wellness & Medspa
-
Manhasset, NY
- MUST HAVE MEDSPA or MEDICAL OFFICE PRACTICE MANAGEMENT EXPERIENCE Are you critical about getting the smallest details ri...
- 4/22/2024 12:00:00 AM
Bcba Assistant Clinical Director
- A and J Behavioral Health
-
Westchester County, NY
- Job Description Job Description The work hours are from 930 am to 530 pm mostly in office. Responsibilities include trea...
- 4/21/2024 12:00:00 AM
Clinic Director / Partner - Licensed Physical Therapist
- Ivy Rehab
-
Bronxville, NY
- Description Position at Ivy Rehab Physical Therapy Clinic Director & Partner (Licensed Physical Therapist) Ivy Rehab Phy...
- 4/20/2024 12:00:00 AM
Clinical Director - Child Guidance Center of Southern Connecticut
- Moses/Weitzman Health System
-
Stamford, CT
- Job Description Summary: Job Description: Organization Information: Location: CGC - Stamford West Broad City: Stamford S...
- 4/20/2024 12:00:00 AM
About Bridgeport, Connecticut
Bridgeport is a historic seaport city in the U.S. state of Connecticut. It is in Fairfield County, at the mouth of the Pequonnock River on Long Island Sound, 60 miles from Manhattan and 40 miles from The Bronx. It is bordered by the towns of Trumbull to the north, Fairfield to the west, and Stratford to the east.
As of 2017, Bridgeport had an estimated population of 146,579, which made it the largest city in Connecticut and the fifth-most populous in New England. The Greater Bridgeport area is the 48th-largest urban area in the United States.
The showman P. T. Barnum was a resident of the cit...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Outcomes Director jobs
$199,635 to $258,239
Bridgeport, Connecticut area prices
were up 1.7% from a year ago
were up 1.7% from a year ago
What does a Clinical Outcomes Director do?
Clinical Outcomes Director in Ventura, CA
Outcomes measurement is the method we use to hold ourselves accountable for achieving our fundamental purpose of “helping people get better”.
February 19, 2020
Clinical Outcomes Director in Gulfport, MS
The Berman Center has been conducting major clinical trials on chronic disease outcomes for the past 50 years.
January 26, 2020
Clinical Outcomes Director in Waco, TX
The disparities have troubled regulators, who are tasked with evaluating the merit of clinical data.
January 09, 2020