Clinical Compliance Manager Job

Employer Name: Confidential	SpiderID: 2470444
Location: Fort Wayne, Indiana	Date Posted: 9/4/2008
Wage:	Category: Biotech
Job Code: 3128

Job Description:
Our client is a worldwide leader in orthopedics and has been very innovative since its founding more than 75 years ago. Their hip and knee joint replacement systems and wide range of related products and services make our client valuable partners to health care providers in 100 countries. This is an exciting opportunity for the right person to join a stimulating work environment focused on being the best – designing and building the best possible systems and delivering the best package of value-added services for their customers.

Job Responsibilities:
1) Support Global Clinical Affairs Team in developing, implementing and tracking of company's compliance program standards as well as federal regulations and guidelines (i.e. GCP, ICH, BSI and FDA)
2) Provide GCP supervision and guidance for clinical research activities by collaborating with various internal and external groups (Data Management, Regulatory, Medical Writing, Biostatistics and study/site managers)
3) Maintain a high level of quality and consistency across the clinical programs
4) Provide guidance to clinical teams on best practices, industry standards and regulations
5) Foster relationships with Clinical Research staff
6) Encourage discussion and evaluate best practices for continuous improvement of quality and compliance across programs
7) Oversee Clinical Compliance staff in Warsaw and assume dotted line accountability for compliance associates at remote offices
8) Provide clinical compliance guidance and consultation to senior management at all clinical affairs locations
9) Evaluate the company needs to establish a first class clinical compliance group
10) Take the lead to internally build the appropriate organization
11) Oversee the surgeon selection and approval process to continue refining the HCP selection criteria
12) Work with Compliance and Legal as well as oversee to expedite the selection and contracting process
13) Ensure that all required documents are available at all reviews
14) Collaborate with Compliance Office to ensure analysis as well as report support DPA and CIA requirements
15) Establish and implement a compliance training plan
16) Direct and/or conduct formal compliance and GCP/ICH trainings
17) Develop internal company procedures to meet GCP compliance requirements
18) Initiate and oversee appropriate internal department and external clinical site audits
19) Prepare SOPs for the clinical compliance function
20) Oversee audit plans, audit reports and institute any necessary corrective or preventative actions to meet procedural or regulatory compliance requirements
21) Initiate follow-up assessments to ensure compliance
22) Participate in the HCP payment process to ensure that all compliance criteria are being met prior to payment requests
23) Review protocol and clinical trial registration documentation for accuracy, completeness and compliance requirements
24) Lead risk assessment and risk mitigation of clinical development projects from a quality perspective
25) Institute any process improvement initiatives necessary across the organization
26) Work with the Research Services Manager in developing systems to request and track quarterly research reports and collaborate with the External Research Division to ensure study progress
27) Oversee and review adverse events reporting as per company procedures and regulatory requirements
28) Ensure team is complying with Title 21 CFR Part 803 Subpart C "Medical Device Reporting – User Facility Reporting Requirements"
29) Perform other duties as assigned

Job Requirements:
1) Bachelor’s/Advanced degree (scientific/healthcare field preferred) with extensive clinical research experience
2) Minimum 5 – 7 years in performing clinical research (auditing experience preferred)
3) Previous supervisory experience preferred
4) In-depth knowledge of the US federal regulations related to clinical research (21 Parts 50, 56, 312, 812 and ICH Good Clinical Practice guidelines)
5) Ability to review clinical protocols, informed consents, monitoring and data management plans and independently make recommendations for improvement
6) Excellent communication, training and written skills
7) Ability to present well-structured assessments to senior management, internal and external groups
8) Ability to promote teamwork by demonstrating excellent interpersonal skills
9) Expertise in application of CFRs, GCPs, ISO, ICH guidelines and FDA regulations for post market outcomes and IDE/IND clinical studies
10) Experience in company ZWIs and SOPs as they apply to HCP interactions and clinical study management
11) Knowledge of product lines and departments within the company
12) Proficiency in MS Office, Internet Explorer, Livelink, JDE and other required software
13) Excellent communication skills (oral and written)
14) Willingness to travel (up to 30% with potential for international travel)

Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-03128.html

Job Criteria:
Start Date: ASAP
Position Type: Full-Time Permanent
Years of Experience Required: 5
Education Required: Bachelors
Overnight Travel:
Vacation Time:

Company Profile:
Our Life Sciences practice provides executive search and recruitment services to pharmaceuticals, medical devices, and biotech industries. We represent venture capital firms and their portfolio life science and contract research companies in matters of executive search and corporate development.

Contact Information:

Contact Name: Jennifer Huston	Company Type: Recruiter
Company: Sterling-Hoffman Life Sciences

City: Toronto
State: Ontario
Zip: M5G 1T6

Web Site: http://www.sterlinglifesciences.com/