Clinical Research Manager

Opportunity to join a leading global biopharma company
- Exciting chance to work with passionate and collaborative teams
- Be at the centre of innovation and excellence in execution.

Our Clinical Research and Pharmacovigilance team pushes global healthcare boundaries through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Reporting to the Therapeutic Area Head, you will be primarily accountable for the end-to-end performance and project management for assigned protocols in a country. You could be responsible for a particular study for several countries in a cluster.

**What will you do**:

- You will be the primary Point of Contact (POC) for assigned protocols and the link between Country Operations and the clinical trial team (CTT). Responsible for project management of the assigned studies: proactively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and close out.
- You will be accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
- You will review, monitor visit reports, and escalate performance issues and training needs to the CRA manager, functional vendor, and internal management as needed. Perform Quality control visits as required.
- You will lead local study teams to high performance: train in the protocol and other local roles, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across the different regional country roles, ensuring a strong collaboration (including the CTC, CRAs, and COM).
- You will create and execute a local risk management plan for assigned studies. Ensure compliance with key systems in assigned studies.
- You will identify and share best practices across clinical trials, countries, and clusters. Will be responsible for collaboration with functional outsourcing vendors, investigators, and other external partners in assigned studies.
- You will be the country POC for programmatically outsourced trials for assigned protocols.
- As a customer-facing role, this position will build business relationships and represent the company with investigators.
- Serve local business needs as applicable and support local and regional strategy development consistent with long‐term corporate requirements in conjunction with CRD, TAH, and Regional Operations.
- Collaborate internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, and Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.

**What should you have**:

- You have a Bachelor's degree in Science (or comparable) with a minimum of 5-6 years of experience in clinical research (CRA Experience preferred)
- You have previous project management experience in oncology, specifically the melanoma indication
- You are an expert in project management with project management certification or a relevant training program. You are excellent in site management with strong organizational skills.
- You can make decisions independently and oversee essential activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head or CRD
- You should have experience in the local regulatory environment, scientific and clinical research knowledge, a strong understanding of clinical trial planning, and the ability to simultaneously multitask on various deliverables and protocols.
- You should have excellent communication (written and verbal) skills to effectively build a collaboration spirit in a remote/virtual environment and across countries, cultures, and functions.
- You have expert-level experience and the ability to manage resource allocation, processes, productivity, quality, and project delivery.
- You are a strategic thinker with strong leadership skills and a great understanding of cultural diversity. You can identify problems, conflicts, and opportunities early to lead, analyze, prepare mitigation plans, and drive conflict resolution.
- You are experienced in negotiating challenging situations with internal and external groups.
- This role might require traveling of up to 20% of working time.
- You are based in Sydney and can attend the Macquarie Park office when required

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at