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Job Title: Manager, Clinical Research
Location: Princeton, NJ United States
Position Type: Full Time
Post Date: 10/09/2021
Expire Date: 12/09/2021
Job Categories: Biotechnology and Pharmaceutical
Job Description
Manager, Clinical Research
The Office of the Vice Provost for Research & Scholarship, Clinical Trials Research Office (CTRO) has an exciting and immediate opportunity for a Manager, Clinical Research at the Coral Gables Campus.



The Manager, Clinical Research oversees the development of clinical trials and research programs that support the overall mission of the University. This role is also responsible for the independent execution of regulatory-related decisions/strategies; and coordinates work with Study Managers and other relevant team members to assure the fidelity of study protocols and data collection.


Works with investigators and study teams to help meet targets and milestones, ensures timely and accurate submission to IRBs, sponsors and master agreements, and coordinates with the Research Program Director on remediation.

Coordinates the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as well as exemption requests.

Assembles project plans, team and work assignments, d
ecting and monitoring work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately.

Manages investigator relationships.

Maintains IND and IDE documentation, including annual reports for delegated studies and works with the primary investigator and project team to assist in responding to queries from regulatory agencies including the FDA.

Tracks proposals and other study relevant documentation through signature/approval processes then through collaboration with Contracts and budgets.

Serves as liaison and facilitates meetings between project stakeholders and leadership and completes and maintains professional documentation for projects and deliverables, develops SOPs as needed, and assists in the auditing and monitoring of studies.

Identifies areas for improvement within daily functions, internal procedures
, an
d regulatory agency interactions.

Interacts with project team members to define submission logistics and workflow scheduling.

Oversees the ongoing maintenance of records detailing the number of active INDs and IDEs and related data via an internal tracking system.

Prepares and presents the annual summary report for clinical trial and research areas.

Provides consultation and guidance for UM held INDs and IDEs.

Develops, implements, maintains and oversees internal policies and SOPs as well as University‐wide policies and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best Practices.

Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures.

Ensures employees are trained on controls within th
e func
tion and on University policy and procedures.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.



Masterís degree in Science, Health care, or related field required.

Certification and Licensing:

Professional certification in at least one of the following areas: clinical research, research compliance, auditing, Good Clinical Practice (GCP) related field, etc., highly preferred.


Minimum 5 years of effective work-related research experience including research compliance/quality assurance and management experience as a department or division director, project leader, or similar role required. Any appropriate combination of rele
vant edu
cation and/or work experience may be considered.
br /> Knowledge, Skills and Attitudes:

Expert knowledge of FDA, HHS, NIH, OHRP, etc., regulations and research related guidance documents.

Ability to communicate effectively in both oral and written form.

Ability to maintain effective interpersonal relationships.

Ability to process and handle confidential information with discretion.

Skill in completing assignments accurately and with attention to detail.

Proficiency in computer software (i.e. Microsoft Office); Information Technology (IT) knowledge.

Ability to communicate effectively in both oral and written form.

Ability to maintain effective interpersonal relationships.

Knowledge of business and management principles.

Ability to direct, manage, implement, and evaluate departmen
t operatio

Ability to establish department goals, and objectives that support the strategic plan.

Ability to effectively plan, delegate and/or supervise the work of others.

Ability to lead, motivate, develop, and train others.
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Contact Information
Contact Email:Mitzi.Sacks@otsuka-us.com
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