Associate Clinical Operations Manager II

3 weeks ago

Midrand, Gauteng, South Africa MSD Full time

Job Description

Brief Description of Position:

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the COM Lead, Head COMs or CRD, the person is responsible for supporting budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals.

Responsibilities include but are not limited to:

  • Support to country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
  • Oversees and tracks clinical research-related payments. Payment reconciliation at study close- out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Support of Financial forecasting in conjunction with COM Lead /other roles.
  • Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
  • Provide support and oversight to local vendors as applicable.
  • Contributes to the development of local Financial SOPs.
  • Support of local regulatory and financial compliance. Ability to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
  • Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related- interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value
  • Contribute or lead initiatives and projects adding value to the business, as appropriate/required
  • Contributes strongly to COM team and other Country Operations roles knowledge by acting as/supporting process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
  • Coordinates local processes, 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 and finance systems.
  • May act as buddy / mentor.
  • Contributes to COM team knowledge by sharing best practices as appropriate/required.

Other responsibilities may include:

  • Contribute to Execution and oversight clinical trial country submissions and approvals for assigned protocols.
  • Develops local language materials including local language Informed Consents and translations.
  • Interact with IRB/IEC and Regulatory Authority for assigned protocols.
  • Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.

Qualifications & Experience:

  • 1-2 years of experience in Clinical Research or experience in Finance/Business
  • Required: Associate degree or equivalent Health Care related experience
  • Preferred: Bachelor's degree

Skills Required:

  • Good IT skills (MS office, Clinical IT applications) and ability to adapt to new IT applications on various devices.
  • Excellent verbal and written skills, in local language and English.
  • Strong coordination and organizational skills.
  • Basic knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study start-ups.
  • Ability to propose solutions to local study teams.
  • ICH/GCP knowledge appropriate to role. Hands on knowledge of Good Documentation Practices.
  • Able to work with other experienced clinical research professionals to learn and develop skills to manage protocols independently. Works with high quality and compliance mindset.
  • Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
  • High sense of accountability and urgency in order to properly prioritize deliverables.
  • Strong communication and negotiation skills in local language and English.
  • Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
  • Positive & growth mindset, capable of working independently and being self-driven.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/17/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:06/17/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R266925

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