Director, Clinical Operations - Bridgewater, United States - Bausch Health

Description

Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry.

We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 7,000 employees are united around our mission of improving people's lives with our health care products.
Overview

Responsible for the implementation and oversight of clinical study or program operations by organizing and coordinating with other relevant parties the planning, implementation, management, execution and completion of clinical studies or programs according to applicable regulations and guidance, ICH and GCP, and Bausch Health Companies Research & Development 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.
May supervise direct/indirect reports including Clinical Trial Manager (CTM), Senior Clinical Research Associates and Clinical Research Associates (Sr. CRAs and CRAs) and Clinical Trial Assistants (CTA)..
Responsibilities
Manage 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 supplies, 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.

Ensure 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 Bausch Health SOPs.

Communicate with relevant global team members, other Bausch Health departments (e.g., Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilence and Drug 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.

Prepare study timelines and budgets and ensuring study execution is aligned with these targets.

Supervise clinical staff to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and Bausch Health 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 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 ECs/IRBs

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 study site personnel and clinical investigators to provide study related guidance and answers to operational issues.

Budgets and Forecasts:

Provide assistance to the Head of Clinical Operations in working with Business Operations to forecast study expenditures and resourcing needs.

With guidance from the Head of Clinical Operations, review RFPs and proposals from external vendors.
Ensure subordinates and vendors manage and monitor study related expenses to meet forecast.
Ensure timely communication of any variances to budget forecast to the Sr. Director or Director of Clinical Operations.
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/DSUR and IB updates are completed in an accurate and timely manner.
Provide Clinical Operations support to the Regulatory Affairs department.

Leadership:

Manage in-house team of Managers and CRAs 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 Managers and/or Clinical Research Associates 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.

Attend related courses, seminars and meetings including SOP training.
Maintain training records.

Read professional journals and publications to stay abreast of current scientific knowledge in particular therapeutic area as well as in applicable guidelines and regulations.

Obtain information from the field on relevant new scientific developments and identify needs for staff training, if applicable.
Share/present knowledge and information with appropriate departmental, project, or study team members for training purposes.
Qualifications

• Strong knowledge of Good Clinical Practices (GCP), clinical trials management (including site monitoring), scientific methods, research design, regulatory compliance, and clinical data management.
• Minimum - 8 years' experience in the industry with approximately - 6 years managing clinical trials.
• 3 – 4 years' experience in managing and training clinical personnel (Managers, Sr. 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.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

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This position may be available in the following location(s):

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We thank you in advance for your interest in growing and developing with our company.

Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one.

Please ensure you have discussed with your current manager the intent of applying to a new role.
Any exception will have to be authorized by your HR Business Partner.
We are an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

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