(Senior) Site Contracts Manager
hace 7 meses
Company Description
Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.
Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia
Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.
We have nourished a true international culture here at Ergomed.
We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
**Job Description**:
**The (Senior) Site Contracts Manager **will be responsible for (but not limited to) the following activities**:
- Oversees negotiations of clinical study agreements (CSA´s) on a study level and drives CSA document finalization and execution, including contractual language & terms, financial attachments, and investigator grant budgets in collaboration with a local and / or global team of site contract & budget negotiators.
- Provides oversight of contact & budget negotiations status and manages escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers in all regions of study conduct. Provides consultation during escalation of out-of-parameter queries as needed.
- Plans contract execution strategy for assigned studies—including forecast of site-specific contractual execution timelines with as much accuracy as possible and coordinates with internal study team stakeholders to ensure that CSA strategy is aligned with overall study start-up delivery plans and expectations overall. Manages expectations of internal and sponsor study team regarding global CSA negotiations for assigned studies.
- Coordinates communications between study team stakeholders and local and / or global team of site-facing site contract & budget negotiators including roll-up of all status updates to regular team forum. Participates in regular study calls to facilitate communication as needed.
- Works closely with internal stakeholders and with Sponsor to prepare site contractual templates, including payment terms, and study-level negotiation parameters and processes within Ergomed’s standards in order to drive successful negotiation of contracts and budgets.
- Establishes strong working relationships and collaboration with Sponsor to ensure site contractual templates fit into the global strategy set for the program.
- Creates and maintains document status reports’ and updates department tools/systems and team members on a regular basis; ensures appropriate documentation is maintained.
- Collaborates with internal and external legal, finance and clinical operations departments, including communicating and explaining legal and budgetary issues.
- Manages site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.
- Accountable for Site Contracts delivery of assigned projects and/or initiatives.
Performs other work-related duties as assigned.
**Qualifications**:
- BS degree in law, business, life sciences, a health-related field, or equivalent combination of education and experience.
- Strong CRO operational experience with a track record in Site Contracts Management working in an international or global capacity.
- Thorough knowledge of applicable regulations, drug development and clinical project management procedures.
- Understanding of the specific country requirements pertaining to Site Contracts delivery in at in one or more regions (but at least in the country of residence) and the ability to work across geographic regions.
- Ability to mentor and coach lesser experienced staff and supports SSU Management on all administrative or departmental activities.
- Good presentation, documentation and interpersonal skills. Proficient in MS Office (Word, Excel and PowerPoint), outlook and Internet.
- Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
- Attention to attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines. Strong leadership skills; ability to teach/mentor lesser experienced team members.
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued
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