What are the responsibilities and job description for the Contract Compliance Officer position at Alimentiv?
POSITION LOCATION: London, ON
POSITION TITLE: Contract Compliance Officer
POSITION REPORTS TO: Sr. Legal Counsel
DEPARTMENT/UNIT NAME: Legal
JOB SUMMARY:
The objective of this role is to ensure that Alimentiv has internal controls that adequately manage the risks we face related to our commercial contracts and to a lesser extent, industry regulations. The Contract Compliance Officer provides an in-house service that effectively supports business areas in their duty to comply with relevant contract terms and Alimentiv’s’ procedures by providing auditing, analysis, and “control” development support. As needed, this person may be a voice to the clients during escalations or audits and as a member of the Alimentiv Legal Department, will work closely with the legal team to ensure terms are understood and any nuances documented clearly for Alimentiv’s operational groups.
AREAS OF RESPONSIBILITY:
- Audit and Review
- Ensure Alimentiv is conducting the clinical research study in full compliance with client contract by partnering with the Legal team to develop an effective legal compliance program – this could be an overall or a study specific guide.
- Regularly audit/monitor procedures, practices and documents to identify areas of potential compliance weakness or risk on higher risk projects.
- Collaborate with cross departmental Quality Training & Compliance (QTC) representatives to ensure current training and processes related to contract compliance are being maintained.
- Support the Quality Department by participating in internal and external audits and facilitate CAPA responses and process changes as needed.
- Operational Support
- In conjunction with functional/department leaders, assess company operations to determine contract compliance risk.
- Assist the clinical operations, IT and Quality departments to ensure they are meeting contract expectations by recommending, co-designing/authoring control methods (where knowledge allows) that are practical for a company of Alimentiv’s size and maturity and that allow our Quality team to demonstrate and defend compliance during audits.
- Support clinical operations teams during the handoff process from Business Development (BD) by identifying specific areas of potential contract compliance concern
- Specifically, make recommendations for revisions to policies or work instructions, staff training, and best practices related to our clinical projects that will ensure the highest possible level of compliance.
- Communications
- Communicate corporate compliance-related issues to leaders across all divisions of the organization.
- Advise management on the company’s compliance with contracts through detailed, annual reports.
- As needed, and in conjunction with senior leadership, Project, QA, Legal and IT, assist with crisis and compliance violation management and communications.
- Participate in external audits when needed.
QUALIFICATIONS:
Applicants should have a minimum of an undergraduate degree and 7-9 years of relevant experience with significant job-related training, or a college diploma/degree with 10 years of related experience. Further, the successful candidate must show a solid understanding of compliance and risk management issues relating to services within the company. Previous management level experience. Experience with formal SOPs, process development required. Demonstrated experience in contracts reviews and recommendations. Related legal regulations will be required although not at a specialist level. Clinical trials project experience is an asset.
WORKING CONDITIONS:
Office based
*Accommodations for job applicants with disabilities are available upon request.
