Site Contracts Associate

Recruiter
Docs International UK Limited
Location
Uxbridge
Posted
03 Dec 2017
Closes
10 Dec 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
DOCS are working closely with aGlobalBiopharma to find the right Contracts Associate to add to their existing team of 7professionals at their busyUxbridge office.

Do you have;

- Good contract negotiation experience in UK and preferrably another EU country
- Understanding of UK Costing template and NHS contracting requirements
- Proactive and enthusiastic personality

If you are looking for a change, the benefits of a full-time, permanent position, and you have 1-2 years' experience of site contracting, please read the summarised description below;

KEY LEGAL RESPONSIBILITIES INCLUDE:

- Primary point of contact for investigator sites to address legal questions and concerns
- Prepares, negotiates and finalises Clinical Trial Agreements (CTAg) with investigator sites including preparation of financial appendix/exhibit (for in-house studies only.
- Primary country liaison with Contracts Center of Excellence (CCE).
- Manages legal exception process for contract negotiations, answers and resolves routine contractual questions independently and promptly escalates legal issues and country specific questions to CCE for advice and tracks resolution.
- Develops and seeks CCE approval for local fallback language on an ongoing basis and revises where appropriate.
- Takes ownership and accountability for maintaining an up to date repository of R&D Legally approved country
- CTAg templates, including amendment templates for in house & outsourced studies, updating where appropriate due to industry, regulatory or BMS policy changes. This also includes site-specific CTAg templates (as required).
- Takes ownership and accountability for maintaining an up to date repository of R&D Legally approved Site ICF back up language (as required)
- Negotiates and maintain Master Agreements with Centers of Excellence where applicable.
- Primary point of contact on indemnity related queries and for consultation on insurance policy requirements.

KEY FINANCIAL RESPONSIBILITIES INCLUDE:

- Primary point of contact for investigator sites to address financial questions and concerns.
- Answers and resolves routine financial related questions independently and promptly escalates complex questions to the Clinical team for advice.
- Interface between the Central Contract and Grant group and hub management to ensure country Site Budget Worksheets are fair, reasonable, adequate, consistent and in-line with local expectations.
- Takes ownership and is accountable for maintaining a repository of approved country SBWs and a repository of institution approved costings including site ancillary costs such as site start-up costs (where required).
- Regular review of PICAS data (standard industry costing) versus country specific clinical procedures costs.
- Negotiates and generates financial exhibit/appendix to all CTAgs.
- Identifies opportunities to negotiate reduction in study costs at certain key Institutions due to high volume of BMS studies being conducted at said locations, if appropriate.
- Manages the financial exception process for contract negotiations by collaborating with financial counterparts and clinical team.
- Responsible for driving the internal fund approval process to ensure timely turnaround of contract signature and clear generation of site financial agreement information.
- Initiates workflows and maintain workflow in contract management and approval system including tracking of financial negotiation timelines.

GENERAL

- Uses excellent negotiating and interpersonal skills when independently dealing with external and internal customers (e.g. Investigator sites, contractors, vendors, accounts payable, finance, legal, and other ancillary groups within the organization as applicable).
- Works well in a team environment with little or no supervision by demonstrating the ability to think in a logical decisive manner and demonstrates a "can do" approach. Utilizes effective problem-solving approaches and independently follows-up and resolves outstanding issues, within deadlines.
- Exhibits professionalism and strong business ethics by maintaining confidentiality where appropriate, exhibiting candor and honesty with both internal and external key stakeholders, and respecting Company policies and privileges.
- Functions independently while coaching other team members within an environment that relies heavily on system and process knowledge.
- Interacts effectively with a wide range of individuals, both external and internal customers, collaborates effectively with internal groups and individuals to achieve key deliverables.
- Communicates effectively using excellent verbal and written skills with both internal and external key stakeholders; coordinates information and document flow to and from both internal and external stakeholders.
- Exhibits flexibility and willingness to develop new skills by being receptive to new systems and processes.
- Seeks to identify and implement best practices within established processes.
- Identifies potential areas for improvement of existing processes and proposes solutions to maximize efficiency.

Compliance

- Perform all of the above duties in an ethical and legally compliant manner, adhering to the BMS Standards of Business Code and Ethics, BMS policies and procedures applicable to the role and relevant local legislation and industry codes of practices
- Contribute to the effective operation of the company's quality management system and maintain the highest standards of quality.
- Alert your line manager or Compliance & Ethics Director to possible compliance issues.
- Report any adverse events or product quality complaints immediately to Medical Information in accordance with the relevant BMS complaint reporting procedures.

Experiences Desired:

- Experience in the conduct of clinical trials in the pharmaceutical industry.
- Proven background in project planning, working on multiple projects in parallel, to tight timelines and obtaining the necessary resources/information to achieve business goals.
- Experience of working in a heavily matrix environment; navigating and networking in a leadership capacity to meet business goals.
- Experience in creating, processing and tracking clinical contracts and financial documents.
- Demonstrated ability to independently negotiate with internal and external customers.
- Demonstrated ability to communicate effectively using excellent written and verbal skills with internal and external customers.
- Demonstrated ability to proactively follow-up and resolve challenging issues.

Knowledge Desired:

- Good understanding of GCP, ICH guidelines and local regulations.
- Strong understanding of the clinical research and development process regarding the execution of clinical trials, with focus on document workflow associated with site contracts and financial administration.
- Good knowledge of the local market with respect to clinical trial costs.
- Strong financial and/or business analytical knowledge with the ability to express opinions and conclusions in a clear, concise and understandable format.

Please apply directly or contact me on ****************************/call *********** for a confidential discussion about the role.