Site Contracts Manager
Il y a 2 mois
**We see human behind every number**
**Site Contracts Manager**
**Location: France (home-based)**
On behalf of our partner, one of the global leaders in clinical research, we are seeking an experienced Site Contracts Manager to join their innovative and collaborative team.
As a Site Contracts Manager, you will be essential in preparation, negotiation and finalization agreements and budgets related to clinical trials and/or overseeing a
Clinical Research Organization responsible for contract negotiations. You will also provide support to the clinical team in the pricing, planning, execution and control of site/investigator budgets and contracts.
**Detailed Job Duties and Responsibilities**
- Responsible for delivery on established targets/measurements.
- Work with global teams to review and analyze contractual terms and conditions. Assess
legal and budget risks in conjunction with team support functions. Partner with Healthcare
Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive
resolution. Escalate as appropriate.
- Analyze investigator fees in relation to fair market value pricing and ensure alignment
with regional standards and the J&J pricing guidelines. Participate in and/or lead approval
escalations as appropriate.
- Provide support for negotiations in confidentiality agreements, informed consent forms
and other ancillary contract documents as required.
- Participate in discussions related to the development of site/investigator budgets
aligned with fair market value.
- Manage the contract amendment lifecycle.
Work with the global CCS team as necessary to review and analyze contractual terms
to reach resolution. Assess risks of budget and legal provisions in conjunction with
members of the CCS team and support functions. Escalate issues as appropriate.
- Work proactively to provide recommendations to improve processes and establish
refinements that reduce cycle time, create savings and improve efficiency in the initiation of
clinical trial sites.
- Assume responsibility for all aspects of legal document and metrics tracking.
- Provide support to review, authorize and/or understand aspects of site payments.
Assist clinical operations or clinical team in ensuring that investigator grants comply with
overall study costs and compliance guidelines.
- CCS management and functional CCS support teams such as, legal, Healthcare
Compliance (HCC), Risk Management, Privacy and other stakeholders to obtain guidance
and escalate issues as appropriate.
- Track all aspects of legal document and metrics. Determine potential needs
for contract amendments and manage amendment lifecycle.
Work proactively to improve processes and establish refinements that reduce cycle
time, create savings and improve efficiency in the initiation of clinical trial sites.
- Adhere to SOPs, ethics and departmental compliance as determined by GCDO management
as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity
with departmental and corporate processes including but not limited to the relevant
processes associated with CCS, GCDO and operating companies. Comply with requests from
QA and auditors.
- Full utilization by timely and accurate time reporting (BEACON).
- If applicable, region specific deliverables will be specified.
- Ensures Inspection readiness by maintaining complete, accurate and timely data
and essential documents in systems utilized for trial management (e.g. SATS) according to
expectations (metrics) and archiving retention requirements.
- Ensure inspection ready and comply with relevant training requirements and
developing therapeutic knowledge to ensure service delivery.
- Advanced:
- Analyze contract requests/needs from operating companies and translating
into appropriate contracts/budgets for company sponsored and investigator initiated
clinical trial agreements and other relevant legal documents as they relate to various
clinical projects. Ensure that contractual terms and provisions are following corporate
process, systems, and strategies.
- May mentor, champion, or represent functional area in process initiatives, as required.
- Autonomy with execution of CCS services.
- Depth of knowledge with CCS services.
- Process leadership.
- Region specific activities (to be specified).
**Education / Qualifications / Skills Requirements**
- 3 years’ experience and/or equivalent competencies in legal/ pharmaceutical
industry/clinical research.
- Excellent communication skills (both oral and written).
- Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor,
etc.).
- Familiarity with clinical research processes.
- Ability to work effectively in cross function teams.
- Able to work independently as well as in a collaborative team environment.
- Strong and proven negotiation and problem resolution skills.
- Working knowledge of PCs (MS Office suite at a minimum) and database management.
- Fluency in English.
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