Program Lead, Nephrology Clinical Studies

1 week ago

Johannesburg South, South Africa Arborvitae.in Full time

Position Overview:
We are seeking a seasoned Program Lead with 15+ years of experience in clinical

operations within the pharmaceutical industry to join our growing team. In this role,

you will provide oversight and leadership for the Nephrology program, encompassing

Phase I-IV clinical trials. You will be responsible for managing the operational

aspects of the program, ensuring that projects are delivered on time, within budget,

and meet quality standards. Additionally, you will oversee financial aspects, including

payments to vendors, clinical trial sites, and other external partners, ensuring

compliance and smooth operations throughout the trial lifecycle.

Key Responsibilities:

- Lead the operational oversight of Nephrology Phase I-IV clinical trials,

ensuring adherence to timelines, budgets, and regulatory requirements.
- Provide strategic direction and leadership for cross-functional teams, including

clinical operations, data management, regulatory, and medical affairs,

ensuring alignment with program goals.
- Oversee site selection, monitoring, recruitment, and training activities for

Nephrology clinical trials.
- Develop and manage program-level budgets, ensuring that resources are

allocated appropriately, and work to optimize cost-efficiency throughout the

program.
- Oversee vendor selection, contract negotiations, and management of

relationships with external partners and service providers.
- Ensure timely and accurate payment processing for clinical trial sites,

vendors, and consultants, ensuring compliance with contractual agreements

and internal financial procedures.
- Collaborate with clinical and financial teams to track and manage trial-related

expenses, identifying any potential risks or discrepancies early and taking

corrective action when needed.
- Act as the primary point of contact for senior leadership and stakeholders on

all aspects of program operations, including progress reporting, operational

risks, and mitigation strategies.
- Provide mentorship, guidance, and leadership to junior team members and

ensure effective team collaboration and communication.
- Stay current with industry trends, regulations, and best practices to

continuously improve the program's operational efficiency and compliance.

Qualifications:

- A minimum of 15 years of experience in clinical operations within the

pharmaceutical or biotechnology industry, with a focus on Nephrology clinical

trials (Phase I-IV).
- Proven track record of successfully managing complex clinical programs, with

experience in both operational leadership and financial oversight.
- Strong understanding of GxP, ICH, and FDA/EMA regulations related to

clinical trials.
- Experience in clinical trial budgeting, financial management, and payments to

sites and vendors.
- Ability to lead cross-functional teams and work collaboratively with internal

and external stakeholders.
- Exceptional communication, negotiation, and problem-solving skills.
- Bachelor's degree in Life Sciences, Clinical Research, or a related field

(advanced degree preferred).
- PMP certification or equivalent project management experience is a plus.

**Job Types**: Full-time, Permanent

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