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PRA Health Sciences: Clinical Operations Manager

PRA Health Sciences

This is a Full-time position in Montreal, QC posted September 23, 2020.

Do you want to watch clinical development change, or do you want to be the one to shape it?

Because we’re hoping you’re here for the latter.

Who are we?We Are PRA.

We are 17,000+ employees strong, operating in more than 90 countries.

We are committed to saving lives and we are constantly striving to be the best at what we do.

Our impact is real and we see it every single day.

We are getting lifesaving drugs into the hands those who need them most.

Who are you?You are a leader that isn’t afraid to delegate, but also isn’t afraid to get your hands dirty.

You look for new and innovative ways to problem solve.

You are the ultimate planner and coordinator and are an excellent communicator.

You have a serious passion for clinical development.

You never settle for what is, but are always pushing clinical development forward to what it could be.

You motivate others to do the same.

Most of all, you want to do it in a place where you’re more than an employee number.

A place you love working.

Still here?

Good.

Because if this is you, we’d really like to meet you.The Clinical Operations Manager has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.What you will be doing: The incumbent must be able to indirectly influence investigators, vendors, external partners and country managers to deliver these commitments.

This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country based regulations, laws and procedures with minimal support from the Clinical Research Director.

The position requires skilled knowledge of budget and contract negotiations, 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 include but are not limited to:The COM is accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.Financial: Ownership of country and site budgets.

Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.

Oversight and tracking of clinical research-related payments.

Payment reconciliation at study close-out.

Oversight of FCPA, Denied Parties Screening and maintenance of financial systems.

Financial forecasting and tracking of operational budget in conjunction with CRD.Country Submissions & Local Language Materials: Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.

Development of local language materials including local language Informed Consents and translations.

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 meetcountry commitments.Responsible for quality and compliance in assigned protocols in the country.

Contributes to the development of local SOPs.

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 submissions, budgets, CTRAs and local milestones.

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 budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestonesWhat you need to have: Bachelor’s Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience5-7 years clinical research experienceExtensive experience in clinical project management and coordinationExpertise of core clinical, regulatory and financial systems, tools and metricsExtensiveknowledge oflocalregulatoryenvironmentandsubmissionandapproval processesStrong communication and leadership skillsStrong negotiation skills as well as excellent influencing and training/mentoring skills both written and verbalAbility to focus on multiple deliverables and protocols simultaneously is essentialAbility to work effectively, also in a remote virtual environment, with a wide range of peopleAdditionally, for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial proceduresStrong coordination and organizational skillsStrong problem solving skillsHas demonstrated the following leadership behaviors:Ethics & Integrity, Focus on Customers, Drive Results, CollaborateTo qualify, applicants must be legally authorized to work in Canada and should not require, now or in the future, sponsorship for employment visa status.PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities.