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Clinical Operations Manager (COM) Job - Canada  

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Posted on : 10 April 2017

Project Description

Clinical Operations Manager (COM)-CLI005786

Description

Today’s Merck is a
global health care leader with a diversified portfolio of prescription
medicines, vaccines and animal health products. Today, we are building a new
kind of healthcare company – one that is ready to help create a healthier
future 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 to
create an environment of mutual respect, encouragement and teamwork. As part of
our team, you’ll have the opportunity to collaborate with talented and
dedicated colleagues while developing and expanding your career.


Project management activities at Global Clinical Trial
Operations (GCTO) are centralized in a regional operations center. At the
Country Operations level, the Clinical Operations Manager (COM) is accountable
for execution and oversight of local operational clinical trial activities and
has ownership, oversight and impact on local regulatory and financial
compliance. The COM reports to the Senior Clinical Operations Manager (Sr. COM).

The COM has a significant impact on how a country can
deliver country-specific trial commitments and objectives especially during
study start-up. The incumbent must be able to indirectly influence
investigators, vendors, external and internal partners to deliver these
commitments. This includes addressing and resolving issues, maintaining
expertise in country-based regulations, laws and procedures with minimal
support from the Sr. COM. The position requires skilled knowledge of the
local ethics, legislation and regulatory environment, submission and approval
processes, development of local Informed Consent as well as other site ready
and ongoing study deliverables.

The position requires the ability to proactively develop
risk management and mitigation plans in the country and resolve issues locally.

Primary
activities/responsibilities:

The COM is accountable for execution and oversight of
operational clinical trial activities in Canada for assigned protocols in
compliance with ICH/GCP and country regulations, Merck policies and procedures,
quality standards and adverse event reporting requirements internally and
externally.

Country Submissions
& Local Language Materials:

Responsible for execution and oversight of clinical trial
country submissions and approvals for assigned protocols. Oversight of local
language materials including Informed Consents translations and approval. Works
in partnership with IRB/IEC and Regulatory Authority in submission and
approval-related interactions for assigned protocols.

Management & Quality Oversight:

Responsible for managing country deliverables, timelines and
results for assigned protocols to meet
country commitments. Responsible
for quality and compliance in assigned protocols in the country. May oversee
contract workers (CTCs) and local vendors as applicable.

Collaboration:

Works in close collaboration internally with GCTO country
operations (CRM, CTC, CRA), CQM, Finance, Medical Affairs, Regulatory Affairs,
PV, Business Compliance, Legal and regional operations, HQ functional areas and
externally with vendors and sites, IRB/IECs and Regulatory Authorities to
ensure country deliverables are obtained for initial and ongoing ethics and
regulatory approval. Collaborates closely with Regional Operations to align
country timelines for assigned protocols. Provides support and oversight to
local vendors as applicable.

Local Process
Oversight:

Oversight and coordination of local processes. Responsible
for clinical and ancillary supplies management, importing and exporting
requirements, supplies destruction, local electronic/hard copy filing,
archiving and retention requirements, and insurance process management. Enters
and updates country information in clinical, regulatory, safety and finance
systems.

Problem solving and Process Improvement is essential to this
position. Requires the ability to pro-actively identify issues and risks,
analyze root cause, and propose solutions to problems and escalate to
management as applicable. Specific examples of common problems include: 1)
Issues in ICF and ethics approval negotiations, 2) Quality and compliance
issues, 3) Regulatory and legal issues, and 4) issues related to functional
area deliverables that could jeopardize protocol milestones.

Qualifications

- Bachelor's Degree (or comparable) in Business
Finance/ Administration/ Life Science or equivalent Health Care related
experience
- Five to seven years clinical research experience
- Extensive experience in clinical project
management and coordination
- Expertise in core clinical, regulatory and
financial systems, tools and metrics
- Extensive knowledge of local regulatory
environment and submission and approval processes
- Strong communication and leadership skills
- Strong negotiation skills as well as excellent
influencing and training/mentoring skills both written and verbal
- Ability to focus on multiple deliverables and
protocols simultaneously is essential
- Ability to work effectively, also in a remote
virtual environment, with a wide range of people
- Strong coordination and organizational skills
- Strong problem solving skills
- Has demonstrated the following leadership
behaviors: Ethics & Integrity, Focus
on Customers, Drive Results, Collaborate
- Language requirements: Bilingual (French and English)

Our employees are the key to our company's success. We
demonstrate our commitment to our employees by offering a competitive and
valuable rewards program. Merck's benefits are designed to support the
wide range of goals, needs and lifestyles of our employees, and many of the
people that matter the most in their lives.

Merck is an equal opportunity
employer, proudly embracing diversity in all of its manifestations.


Search Firm Representatives

Please Read Carefully:

Merck is not accepting unsolicited assistance from search firms
for this employment opportunity. Please, no phone calls or emails.
All resumes submitted by search firms to any employee at Merck via-email, the
Internet or in any form and/or method without a valid written search agreement
in place for this position will be deemed the sole property of Merck. No
fee will be paid in the event the candidate is hired by Merck as a result of
the referral or through other means.

Job: Clinical Research Generic

Job Title:Sr. Spclst, Clinical Research

Primary Location: NA-CA-QC-Montreal (Kirkland)

Employee Status: Regular

Number of Openings: 1

Company Trade Name:Merck


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