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Position Purpose:
The Clinical Operations Manager (COM)/COM-Finance (COM-F)/COM-Regulatory (COM-R) is accountable for performance and compliance for assigned protocols inacountryincompliancewithICH/GCPandcountryregulations, Client policiesandprocedures,qualitystandardsandadverseeventreportingrequirementsinternallyandexternally.
The COM/COM-F/COM-R, under the oversight of the Senior Clinical Operations Manager (SCOM) or Clinical Research Director (CRD),is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure site ready.
Primary Duties:
General
Manages countrydeliverables,timelines,andresultsforassignedprotocolstomeetcountrycommitments including:
- Quality and compliance in assigned protocols in country
Coordinates and liaises with Clinical Research Managers (CRMs), Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs), Finance and Legal if appropriate to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
Collaborates closely with Headquarter to align country timelines for assigned protocols
Provides support and oversight to local vendors as applicable
Oversees CTCs as applicable
Contributes to the development of local SOPs
Oversees and coordinates local processes,clinical and ancillary supplies, import and export requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management
- Enters and updates country information in clinical and finance systems
Contributes or leads initiatives and projects adding value to the business
Contributes strongly to the COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required
Contributes to COM team and other Country Operations roles’ knowledge by acting as a buddy/mentor and as a process Subject matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required
Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
Adheres to EP and Client SOPs and processes
Finance:
Has ownership of country and site budgets including:
- Development, negotiation, and completion of Clinical Trial Research Agreements (CTRA)
- Oversight and tracking of clinical research‐related payments
- Payment reconciliation at study close‐out
- Oversight of Foreign Corrupt Practices Act (FCPA), Denied Party Screening/Office of Foreign Assets Control (DPS/OFAC) and maintenance of financial systems
- Financial forecasting in conjunction with SCOM, CRDand other roles
Influences investigators, external partners, and country operations to adhere to budget targets and agreed payment timelines.
Regulatory:
Executes and oversees clinical trial country submissions and approvals for assigned protocols including:
Development of local language materials including local language Informed Consents and translations
Interactions with IRB/IEC and Regulatory Authority for assigned protocols
Skills and Education:
Bachelor's Degreein Business Finance/ Administration/ Life Science or equivalent Health Care related experience required
5‐7 years clinical research or combined experience in Clinical Research and Finance/Businessrequired
Expertise of core clinical systems, tools, and metrics
Excellent verbal and written influencing and training/mentoring skills, in local language and English
Strong coordination and organizational skills
Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up
Able to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager.
Ability to make decisions independently with limited oversight from SCOM or manager
Requires a strong understanding of local regulatory environment
Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally
Ability to lead a team of CTCs as applicable
Problem solving is essential
Ability to proactively identify issues and risks, analyze root cause and propose solutions and escalate as applicable
Effective and efficient time management, organizational and interpersonal skills, and conflict management skills
High sense of accountability and urgency to prioritize deliverables
Expertise of core clinical, regulatory, and financial systems, tools, andmetrics,
Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills
Ability to focus on multiple deliverables and protocols simultaneously
Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people
Positive mindset, growth mindset, capable of working independently and self - driven
Ability to directly influence site staff
Great News! We've discovered an exciting live job opportunity for a Clinical Operations Manager - FSP position in Turkey. This job is currently open for hiring/recruiting by Parexel, exclusively for you at Turkey Jobs Expertini. Feel free to download the job details here.
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The work culture at Parexel must adhere to the Ethics of Work Culture as described in the Ethical framework of the UN Charter. You can gain more insights into their local workplace environment by exploring their jobs Parexel and also by visiting their official website through Google.
The World Cities Report 2020 sheds light on the intrinsic value of sustainable urbanization in Turkey, particularly within Turkey. It explores this value from economic, social, and environmental angles, encompassing the intangible aspects that contribute to Turkey's distinct character. Moreover, the report delves into the role of innovation and technology, the responsibilities of local governments, targeted investments, and the effective implementation of the New Urban Agenda in promoting sustainable urbanization globally. For a deeper dive into population growth trends and diversity in Turkey, additional details can be found on Turkey Wikipedia.
Clinical Operations Manager - FSP jobs are available in Turkey.
Exploring the cost of living in Turkey. At Expertini.Com for Turkey , we gauge it based on the percentage of earnings to living costs, typically ranging from 33% to 65% of your monthly income. This analysis empowers you to make informed decisions about your financial planning and lifestyle. Additionally, we recommend consulting with locals before making any moves to a new town.
The average salary range for Clinical Operations Manager - FSP in Turkey varies, but the standard pay scale is rated "Standard" in Turkey. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively.
To apply for a job at Parexel follow the application process following the "Apply Now" button at Turkey Jobs Expertini and also you can visit Parexel official career page and follow their application process.
Key qualifications for Clinical Operations Manager - FSP typically include a list of qualifications and expertise as outlined in Bureau of Labor. Be sure to check the specific job listing for detailed requirements and qualifications.
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Benefits for Clinical Operations Manager - FSP positions may include a list of benefits. These can vary from company to company, so it's important to review the specific job listing for details on benefits offered by the employer.
Not all jobs have remote job opportunities available. However, nowadays, many companies offer remote work options. You can find remote job listings for Clinical Operations Manager - FSP on Turkey Jobs Expertini.
To improve your chances of getting hired for Clinical Operations Manager - FSP, consider improving your skills. Also, make sure to check your Resume/CV Score with our free Resume Scoring Tool. Additionally, it is worth noting that Turkey Jobs Expertini has an in-built Ai Resume Scoring tool that will give you the matching score for each job based on your Resume/CV once it is uploaded. This can also help you align your Resume/CV according to the job requirements and enhance your skills if you fall short of them.
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