Job Posting

Clinical Compliance

  • Location: Cambridge, MA
  • Type: Temp to Hire
  • Job #4916

Job Title: Clinical Compliance
 

Duties: Under the direction of the Senior Director of Clinical Oversight and Systems, the primary responsibility of the Clinical Compliance Specialist is to liaise with various clinical development functions and external groups including Contract Research Organizations (CROs) to ensure a high level of quality and consistency across the programs and assist project teams in promoting a culture of sustainable compliance and Inspection Readiness.

Summary of Key Responsibilities

• Provides day-to-day support and problem-solving expertise to clinical development functional areas to ensure business operations are conducted in full compliance with all relevant policies and procedures.

• Prepares team for internal audits of clinical programs, review route cause analysis and propose reasonable remediation strategies according to relevant policies/procedures

• Partners with Quality Assurance on developing risk-based quality assurance strategies to support Clinical Operations activities

• Partners with Quality Assurance and clinical oversight roles on tracking, trending and reporting of key quality risks to Senior Management

• Provides support to Sr. Director with fostering and strengthening the strategic partnership relationships with CROs

• Assists in the review and identification of potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation.

• Reviews and monitors corrective and preventative action plans (CAPAs) within clinical operations and assists in root cause analysis and formulating responses

• Assists with Inspection Readiness strategy and execution for programs approaching regulatory approval submissions by partnering with QA and program Ops lead

• Participates in process improvement initiatives for clinical operations

• Assists with effective cross-functional collaboration around SOP development

• Participates in the Clinical Quality Assurance Council (CQAC), Joint Operating Committee (JOC) meetings and program team meetings, as appropriate

• Reviews key study plans specific to sponsor oversight and compliance such as the Vendor Oversight Plan

• Maintains knowledge of regulatory agencies' activities, regulations and guidelines relevant to Clinical Development

Skills:

• Proven excellence in operational strategy: experience with developing, implementing, and measuring the impact of clinical operations tools and processes

• Experience in all study phases and experience in rare medical conditions preferred.

• Previous regulatory inspection experience preferred.

• Comprehensive and current regulatory knowledge, including GCPs

• Excellent leadership and organizational skills and ability to deal with competing priorities• Effective communication skills (written, verbal and presentation)

• Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve

• Proficient with MS Office Suite (Excel, Word and PowerPoint).

Education:

• Bachelor's Degree is required.

A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred

• At least 7+ years of biopharmaceutical experience

KEYWORDS

AUDITS 
BIOPHARMACEUTICAL 
BUSINESS OPERATIONS 
CLINICAL OPERATIONS 
CLINICAL PROGRAMS  
Additional Skills: 
EXCEL 
INTERNAL AUDITS 
MS OFFICE 
OPERATIONS 
ORGANIZATIONAL SKILLS 
POWERPOINT 
PROBLEM-SOLVING 
PROCESS IMPROVEMENT 
QA 
QUALITY ASSURANCE 
REMEDIATION 
ROOT CAUSE ANALYSIS 
SOP 
WORD 
AUDIT 
COMPLIANCE SPECIALIST 
MBA 
MICROSOFT EXCEL 
MICROSOFT OFFICE 
MICROSOFT POWERPOINT 
MICROSOFT WORD 
PHARMD 
RN  
Languages: 
English
        Read
        Write
        Speak

Start Date: 08/06/2019
Estimated End Date: 01/02/2020
Hours Per Week: 40.00

 

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