CenterWatch

1+ months

Clinical Compliance Manager I

Kelly Services
North Chicago, IL 60064
**Clinical Compliance Manager I** **-North Chicago, IL**



**Hours: 40 hours per week/Monday - Friday**



**Pay rate: Up to $47.50/hour**



**Contract Length: 18 months**



**NOTE:** this assignment will start as full-time until the end of June 2020, the go to part-time (20 hours a week).



Must have:

they have a broad GCP experience as well as CAPA management experience.



**Top skills:**



a. Required Skill 1: excellent decision making

b. Required Skill 2: excellent written and verbal communication

c. Required Skill 3: strong project management skills

d. Required Skill 4: GCP expertise

e. Required Skill 5: CAPA Management (i.e.investigation, root cause analysis, impact assessment, development of corrective action and preventive action plans, effectivity checks)

f. strategic thinking and critical thinking skills.



**Qualifications :**




+ 6+ years of Pharma-related/clinical research related experience; 2 + years of experience preferably with clinical research, regulatory, compliance and/or quality control; Bachelors degree, typically in nursing or a scientific field. An Associates degree/R.N. with relevant experience is acceptable.

+ Must have demonstrated a high level of core and technical competencies through management of various aspects of clinical trials (e.g., audits, study oversight, SOP development, quality assessments)

+ Possesses good communication skills, demonstrated leadership abilities and problem solving skills.

+ Demonstration of successful coaching/ mentoring in a matrix environment

+ Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).

+ Preferred global exposure from study initiation through study completion in multiple phases of studies (Phase 1-3, 4).



**Purpose :**

Describe the primary goals, objectives or functions or outputs of this position.

Responsible for the overall assessment of compliance, quality control and/or standards defined for the execution of clinical trial(s); including managing CAPA, supporting process improvement initiatives and preparing/analyzing metrics. will matrix manage with assigned therapeutic area or functional partners to ensure proper documentation of AbbVie procedures, implementation of process changes, ensure compliance and/or execution on timelines and quality deliverable. Is aware of both internal and external business environments, assesses impact on the processes for clinical study execution and assists in making modification as necessary. Develops initial interpretation of relevant regulations and guidelines and act as a SME for Clinical Operations. Assist clinical teams with inspections, audit responses and consult on root cause analysis, as required. Takes initiative to resolve problems and mitigate risk.

**Responsibilities :**

List main responsibilities for the job. Include information about the accountability and scope.

Responsible for compliance with applicable Corporate and Divisional policies and procedures.

Provides management of clinical compliance, quality and standards projects within Clinical Operations; prepares key performance indicators

Provides input on new/updates to SOPs, guidelines, work instructions as well as make initial gap assessment of impact of new regulations.

Effectively communicates project progress/compliance concerns and actively identifies issues that potentially impact evaluable study data, ethics I study conduct and ICH compliance and identify potential interventions or solutions to manage the issues.



**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resumes. Thank you for your interest in the assignment.



**Also, feel free to follow up via email to RACS113@KELLYSERVICES.COM**






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-08-30 Expires: 2019-10-21

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Clinical Compliance Manager I

Kelly Services
North Chicago, IL 60064

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