Clinical Operations Manager Job - South Africa
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MSD 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 global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
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 position 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 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 CRD. 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.
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, MSD 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. 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 meet country 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, analyse 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 milestones.
- Bachelor's Degree (or comparable) / Life Science or equivalent Health Care related experience
- 3-7 years clinical research experience
- Extensive experience in clinical project management and coordination.
- Expertise of 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.
- The 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.
- Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures.
- Strong coordination and organizational skills.
- Fluency in English
- Strong problem solving skills
Has demonstrated the following leadership behaviours:
- Ethics & Integrity
- Focus on Customers
- Drive Results
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. Our Company’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.
If you have not been contacted within 28 days after the closing date of this advertisement, please accept that your application was unsuccessful.
MSD is committed to equality, employment equity, and diversity. In accordance with the employment equity plan of MSD and its employment equity goals and targets, preference may be given, but is not limited, to candidates from under-represented designated groups. MSD reserves the right not to make an appointment as advertised. Candidates with disabilities are encouraged to apply for positions.
Job: Clinical Research Generic Job Title:Sr. Spclst, Clinical Research
Primary Location: EMEA-South Africa-Gauteng-Johannesburg
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
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