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Senior Clinical Trial Manager: Becton Dickinson & Company (BD)

Manages clinical trial operations of large and/or complex multicenter studies. Provides oversight and direction to members of a large, multidisciplinary project team throughout the conduct of assigned clinical trials, under the guidance of the Director of Clinical Operations/Affairs. Oversight accountability for Clinical Research Associates.

PRINCIPAL ACCOUNTABILITIES:

1. Provides significant input into clinical and regulatory strategy sessions for assigned projects. Develops and implements clinical trial protocols and operational plans which are consistent with strategic corporate and departmental objectives and assumes primary accountability for the ongoing progress of those plans on assigned studies. Primary interface to clinical investigators and Key Opinion Leaders (KOLs), ensuring their input into protocols, reports, and publications.

2. Manages resources and timelines associated with all study start-up activities, including investigator agreements, central IRBs, regulatory documents, contractual agreements, and device shipment authorizations. Manages the identification, recruitment, and selection of investigators and testing laboratories for planned studies.

3. Ensures the appropriate development of study documents, including informed consent forms, case report forms and instructions, site selection materials, procedural manuals, project newsletters, and other project-specific documents required for the conduct of assigned studies with relatively little oversight.

4. Assumes primary accountability for assigned clinical trials and ensures compliance with applicable regulations, guidelines, and corporate policies for trial activities. In conjunction with the Director of Clinical Operations/Affairs and departmental working practices, ensures the development and maintenance of project-specific tracking systems to enable proper trial management and monitoring activities. Ensures operational and regulatory integrity of assigned trials by reviewing enrollment status reports, monitoring site visit reports, expense reports, memos to file, telephone contact reports, and CRO documentation.

5. Provides daily direction to CRO Project Managers and TriPath Clinical Operations/Affairs project team members as required to meet project objectives. Assumes primary accountability for ensuring that the Clinical Operations/Affairs team members meet the overall project objectives within the timelines and budgets established by the Director of Clinical Operations/Affairs and VP of Regulatory and Clinical Operations/Affairs. Develops and maintains detailed timelines and resource projections for assigned projects. Provides routine status reports and updates to the Director of Clinical Operations/Affairs regarding the progress of assigned studies.

6. In collaboration with the Director of Clinical Operations/Affairs, identifies and evaluates internal and/or external resources required for assigned clinical trials. Independently manages external partners for outsourced work.


7. Assumes primary accountability for planning and managing Investigator's Meetings, Project Training Meetings, Steering Committee Meetings, DSMB meetings, Adjudication Panels, etc. associated with assigned clinical trials. Represents TriPath Clinical Operations/Affairs Department as required.

8. Manages personnel responsible for the distribution of documents, forms, supplies, equipment, laboratory supplies, and study device required to execute clinical trials. Plans and implements study supply activities to ensure that all materials needed to execute the study are available when needed.

9. Serves as a manager to Clinical Research Associates assigning them to project(s) and maxtrixing with CTMs to ensure compliance with applicable Monitoring Plans, regulations, guidelines, and corporate policies. Has direct accountability for contract CRA with review and approval of monitoring reports and timesheets. Assigns contract CRAs to BD CRAs for BD monitoring oversight.

10. Assumes primary accountability for ensuring that internal project team members are trained appropriately to ensure proper study conduct.

11. Writes and oversees the creation of internal and external memos, reports, documents, and correspondence required to properly manage and document activities on the studies. Ensures maintenance of project files according to applicable regulations, guidelines, and corporate policy.

12. Interacts with Data Management personnel as needed to resolve data queries and lock the clinical database(s) quickly and efficiently. Interacts with Biostatistics and Medical Writing personnel as needed to analyze and report the study(ies). Authors final clinical report, in conjunction with Director of Clinical Operations / Affairs, including input from investigators and KOLs.

13. In conjunction with the Director of Clinical Operations/Affairs, plans, implements, and documents auditing activities on assigned projects. Participates in FDA inspections as required.

14. Serve as a resource/mentor to Clinical Trial Managers.


JOB DIMENSIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Language Ability:
Ability to read, interpret, and develop clinical protocols and all associated study materials. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations. Ability to write Clinical reports and protocols, business correspondence, and procedure manuals. Excellent communication skills including the ability to effectively present information and respond to questions from project teams, external vendors, clients, customers, and the general public. Prior experience working with investigators and Key Opinion Leaders required.

Operations Ability:
Ability to operationalize complex clinical trial programs by establishing and maintaining systems and processes necessary to control and report trial status and activities. Ability to manage project teams to ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.

Computer Skills:
Microsoft Project, Microsoft Word, Microsoft Excel , Internet software, E-mail, Database software

Supervisory Responsibilities:
The Senior Clinical Trial Manager serves as the matrix manager of team members assigned to large project teams and is responsible for carrying out supervisory responsibilities in accordance with the organization's policies and applicable laws, as directed by the Director of Clinical Operations/Affairs. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Senior Clinical Trial Manager has direct reports of CRA and SCRA and will assign them to project teams on a clinical trial. Additionally the SCTM has accountability for contract CRA monitoring report approvals, expense report approvals, and timesheets.


Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

While performing the duties of this job the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals and human or animal tissue.
The noise level in the environment is quiet to moderate.

Accommodations:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience Required:

• Bachelor's degree in Medical Technology, biochemistry, or related life science field.
• Three years previous experience managing prospective clinical in vitro diagnostic (IVD) trials required.
• Experience managing project team personnel required.
• Three year minimum requirement managing people.
• Experience leading project teams through the start-up, trial conduct, data management, and report writing of FDA regulated prospective IVD clinical trials required.
• Knowledge of ICH guidelines, FDA regulations, and guidelines for clinical diagnostic trials required.
• Ability to work on problems of diverse scope where minimal direction is given for situational analysis. Ability to exercise judgment within broadly defined practices and policies to determine appropriate action. Normally determines methods and procedures on new assignments and provides guidance to lower level personnel.
• Ability to manage stringent deadlines required. Proven ability to provide solutions to a variety of technical problems of moderate scope and difficult complexity required.

Education and Experience Preferred:

• Higher education strongly preferred.
• Previous experience managing and designing PMA IVD clinical trials strongly preferred.
• Experience with site selection and managing international diagnostic clinical trials desired.
• Knowledge of international trial (evaluations) preferred. PMA trial experience strongly preferred.

Supervisory Responsibility:

• Matrix management of 4-40 multidisciplinary project team members, depending upon project assignment and number of contracted monitors.
• Clinical Research Associates will report directly to this position.

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