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Clinical Operations Manager (COM) Job Kirkland Canada,  

Posted on : 10 April 2017

Project Description

Clinical Operations Manager (COM)-CLI005786DescriptionToday s Merck is aglobal health care leader with a diversified portfolio of prescriptionmedicines, vaccines and animal health products. Today, we are building a newkind of healthcare company  one that is ready to help create a healthierfuture for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill,diversity and teamwork of an individual like you. To this end, we strive tocreate an environment of mutual respect, encouragement and teamwork. As part ofour team, you ll have the opportunity to collaborate with talented anddedicated colleagues while developing and expanding your career.Project management activities at Global Clinical TrialOperations (GCTO) are centralized in a regional operations center. At theCountry Operations level, the Clinical Operations Manager (COM) is accountablefor execution and oversight of local operational clinical trial activities andhas ownership, oversight and impact on local regulatory and financialcompliance. The COM reports to the Senior Clinical Operations Manager (Sr. COM).The COM has a significant impact on how a country candeliver country-specific trial commitments and objectives especially duringstudy start-up. The incumbent must be able to indirectly influenceinvestigators, vendors, external and internal partners to deliver thesecommitments. This includes addressing and resolving issues, maintainingexpertise in country-based regulations, laws and procedures with minimalsupport from the Sr. COM. The position requires skilled knowledge of thelocal ethics, legislation and regulatory environment, submission and approvalprocesses, development of local Informed Consent as well as other site readyand ongoing study deliverables.The position requires the ability to proactively developrisk management and mitigation plans in the country and resolve issues locally.Primaryactivities/responsibilities:The COM is accountable for execution and oversight ofoperational clinical trial activities in Canada for assigned protocols incompliance with ICH/GCP and country regulations, Merck policies and procedures,quality standards and adverse event reporting requirements internally andexternally.Country Submissions& Local Language Materials:Responsible for execution and oversight of clinical trialcountry submissions and approvals for assigned protocols. Oversight of locallanguage materials including Informed Consents translations and approval. Worksin partnership with IRB/IEC and Regulatory Authority in submission andapproval-related interactions for assigned protocols.Management & Quality Oversight:Responsible for managing country deliverables, timelines andresults for assigned protocols to meetcountry commitments. Responsiblefor quality and compliance in assigned protocols in the country. May overseecontract workers (CTCs) and local vendors as applicable.Collaboration:Works in close collaboration internally with GCTO countryoperations (CRM, CTC, CRA), CQM, Finance, Medical Affairs, Regulatory Affairs,PV, Business Compliance, Legal and regional operations, HQ functional areas andexternally with vendors and sites, IRB/IECs and Regulatory Authorities toensure country deliverables are obtained for initial and ongoing ethics andregulatory approval. Collaborates closely with Regional Operations to aligncountry timelines for assigned protocols. Provides support and oversight tolocal vendors as applicable.Local ProcessOversight:Oversight and coordination of local processes. Responsiblefor clinical and ancillary supplies management, importing and exportingrequirements, supplies destruction, local electronic/hard copy filing,archiving and retention requirements, and insurance process management. Entersand updates country information in clinical, regulatory, safety and financesystems.Problem solving and Process Improvement is essential to thisposition. Requires the ability to pro-actively identify issues and risks,analyze root cause, and propose solutions to problems and escalate tomanagement as applicable. Specific examples of common problems include: 1)Issues in ICF and ethics approval negotiations, 2) Quality and complianceissues, 3) Regulatory and legal issues, and 4) issues related to functionalarea deliverables that could jeopardize protocol milestones.Qualifications- Bachelor's Degree (or comparable) in BusinessFinance/ Administration/ Life Science or equivalent Health Care relatedexperience- Five to seven years clinical research experience- Extensive experience in clinical projectmanagement and coordination- Expertise in core clinical, regulatory andfinancial systems, tools and metrics- Extensive knowledge of local regulatoryenvironment and submission and approval processes- Strong communication and leadership skills- Strong negotiation skills as well as excellentinfluencing and training/mentoring skills both written and verbal- Ability to focus on multiple deliverables andprotocols simultaneously is essential- Ability to work effectively, also in a remotevirtual environment, with a wide range of people- Strong coordination and organizational skills- Strong problem solving skills- Has demonstrated the following leadershipbehaviors: Ethics & Integrity, Focuson Customers, Drive Results, Collaborate- Language requirements: Bilingual (French and English)Our employees are the key to our company's success. Wedemonstrate our commitment to our employees by offering a competitive andvaluable rewards program. Merck's benefits are designed to support thewide range of goals, needs and lifestyles of our employees, and many of thepeople that matter the most in their lives. Merck is an equal opportunityemployer, proudly embracing diversity in all of its manifestations. Search Firm RepresentativesPlease Read Carefully:Merck is not accepting unsolicited assistance from search firmsfor this employment opportunity. Please, no phone calls or emails.All resumes submitted by search firms to any employee at Merck via-email, theInternet or in any form and/or method without a valid written search agreementin place for this position will be deemed the sole property of Merck. Nofee will be paid in the event the candidate is hired by Merck as a result ofthe referral or through other means.Job: Clinical Research GenericJob Title:Sr. Spclst, Clinical ResearchPrimary Location: NA-CA-QC-Montreal (Kirkland)Employee Status: RegularNumber of Openings: 1Company Trade Name:Merck Job Segment: Operations Manager, Clinic, Medical, Law, Operations, Healthcare, Legal


Montreal (Kirkland), QC, CA

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