Clinical Project Manager 3

Job Description

Title: Clinical Project Manager III
Location: Lexington, MA, United States
Duration: 06+ Months

Job Details:
• Responsible for the planning, implementation, execution and management of one or more complex clinical research studies.
• Manages clinical outsourcing to CROs and other vendors such as IRT, central and specialty labs, etc.
• May author, review and approve various study related documents and plans.
• Evaluates issues, interprets data, and suggests and implements solutions and mitigation as required.
• Leads cross-functional team and is responsible for the financial management of the study (ies).


Responsibilities
% of Time Job Function and Description
10 %:
• Represents and leads the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline
• Authors/contributes to clinical study documents.
• Reviews and approves study related plans generated by Clinical CROs and vendors
• Provides input as the subject matter expert for the study during regulatory inspections.
• 40%
• Responsible for the clinical review and/or approval of CRFs, completion guidelines and the data review plan
• Responsible for oversight of identification and selection of investigator sites.
• Responsible for planning and conducting investigator's meetings.
• Provides input and coordinates the delivery of clinical trial supplies in collaboration with Clinical Supply team.
• Collaborates with the cross-functional team on selection and management of clinical vendors.
• Liaises and coordinates with document specialists regarding study files.
• Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.

40 %:
• Trains and manages CRO and other clinical vendor activities to ensure the quality meets Client and regulatory requirements.
• Monitors the status of clinical data collection of assigned clinical studies.
• May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
• Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.
• Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact.
• Responsible for maintaining tracking information in the clinical trial management system, confirming resolution of data quality issues with the CRO.
• Reviews correspondence and monitoring reports relating to the study.
• Evaluates CRO and vendor performance for future work.
• Provides periodic status reports regarding study timelines, budget issues, accruals, etc. to Global Clinical Programs Lead (CPL) as requested.

5%:
• Develops and monitors budget for clinical study, and reviews budgets and contracts with CROs, vendors, and investigative sites (as applicable).
• Requests and critically evaluates proposals and change orders from CROs and vendors.
• Leads team through selection process and provides input into contracts, change orders, and/or work orders.

5%:
• Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
• Supports department initiatives and process improvements.
• May mentor other Study Managers.

Qualifications

Education and Experience Requirements

• Include educational requirements or equivalency, required years and type(s) or experience, and necessary licenses or certificates. Specify which are required and which are preferred. For UK, please do not use years of experience due to UK Legislation
• Bachelor's degree is required. Scientific/health care field preferred, but not required.
• Experience (5+ years) working in clinical research within a pharmaceutical company or CRO or similar organization.

Key Skills, Abilities, and Competencies

• Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Strong knowledge of applicable computer and project management software packages, including Microsoft Word, Excel, Project, and Power Point
• Familiarity with financial budgeting and forecasting or reporting
• Requires strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
• Ability to work successfully within a cross-functional team and a matrix organization.
• Excellent written and oral communication skills.
• Ability to interact with investigators, vendors, and individuals at all levels of the organization.
• Working knowledge of current global regulatory requirements and guidelines governing clinical research.

Complexity and Problem Solving

• Describe the decisions made by the incumbents on a regular basis. Include decisions within the
• Incumbent's authority to make as well as those decisions that must be referred to a higher level.
• Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints.
• Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
• Ability to work with minimal supervision, take initiative and complete tasks to deadlines, and resolve/escalate problems in a timely manner.

Additional Information

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

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