Clinical Trials Manager

Job Description:$124,500 with a 12 to 15% bonusJob Description Accountabilities:

• Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome
• Work may include policy changes or recommendations
• Individual contributor with specialized knowledge
• Has an easily discernible impact on the job area and expected results
• Typically no cost center budget management responsibility

Complexity / Innovation:

• Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures
• Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
• Called upon to develop solutions utilizing creativity and ingenuity

Communication:

• Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues
• Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity

Supervision Given / Received

• Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees
• Work is completed under limited supervision
• Typically reports to an Associate Director or above

CDP Development and Management:

• Supports the planning, execution and reporting of clinical programs/ trials

Clinical Research Protocols

• Reviews Clinical Protocols

Study Management

• Reviews study documents (i.e., investigator databases, ICFs, IEC/ IRBs submissions)

Clinical Research Expert

• Contributes to risk resolution by escalating and monitoring projects risks

Resource Management

• Makes recommendations for improving resources (tools, systems, vendors, etc.) needed by the team
• Manages the workflow of others to ensure work is done within a given deadline
• May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines

Financial Management:

• Tracks the expenses of work teams to anticipate cost issues
• Manages the use of financial standards, guidelines and compliance for more informed and empowered decisions
• May assist the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalate issues when appropriate

Matrix and Team Management:

• Provides feedback, sets clear tasks and objectives and coaches team members on a periodic basis
• May support employees by providing input into recruitment, selection, performance, succession, and transition activities
• Trains team members on processes and / or systems

People Management (if assigned direct reports):

• Manages individual contributors
• Manages all employee-related activities throughout the year, including performance management and development
• Identifies and communicates the skills, behaviors and experiences required to develop employees
• Sets goals, reviews performance and provides feedback on a regular basis
• Assists or Leads training of junior staff

Compliance:

• Complies with all applicable laws / regulations of each country in which we do business
• Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians
• Reports legal, compliance and ethical violations in a timely manner

Qualifications and Experience:

• MS or PhD
• Experience in Clinical Research methods and processes required.
• Previous experience with Oncology Clinical Research studies is required. Position requires attention to detail, and medical knowledge would be beneficial.

Foundational knowledge in:

• Clinical Trial Design and Execution.
• Clinical Development Planning.
• Regulatory Management.

Job Qualifications Qualifications and Experience

• MS or PhD
• Experience in Clinical Research methods and processes required.
• Previous experience with Oncology Clinical Research studies is required. Position requires attention to detail, and medical knowledge would be beneficial.

Foundational knowledge in:

• Clinical Trial Design and Execution.
• Clinical Development Planning.
• Regulatory Management.

Bachelor degree or above in scientific or related field Minimum 5-7 years experience in Data Management with experience in managing projects, project teams. Experience with In-Form or other EDC software is desirable however, should have some experience in supporting Oncology studies. Must be able to work independently. Proficiency on all related regulations, GCP, and Good Clinical DM Practice. Project management skills required. Strong oral and written communication skills. - Leadership skills a must

**Best Regards,Anuj Mehta973-967-3402