Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations.
Responsible for delivery on established targets/measurements.
Responsible for analyzing 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 in compliance with corporate process, systems, and strategies.
Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information.
Participate in and/or lead the approval escalation of grants as appropriate.
Work with the global C&G team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language.
Assess risks of budget and legal provisions in conjunction with members of the C&G team and support functions and communicate such to stakeholders.
Liaise with C&G management and functional C&G support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
Assume responsibility for all aspects of legal document and metrics tracking.
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. Mentor and train new contract coordinators and analysts.
This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.
Travel: Some travel required. The ability to travel up to 10% of the time
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 C&G GCDO and operating companies. Comply with requests from QA and auditors.
Able to work independently as well as in a collaborative team environment
CONNECT Develop deep insights into the needs of our patients, customers, markets and communities. Cultivate external relationships and partnerships Be insight-driven to uncover unmet needs Forge internal collaboration across all levels of the enterprise
SHAPE Drive innovation; anticipate and shape industry and market changes to advance health care globally. Translate insights into viable products and solutions that create value Take and manage risks Challenge the status-quo; lead and adapt to change
LEAD Create an environment where leadership and talent development is top priority. Take ownership for talent acquisition, performance and development of self and others Maximize the power of diversity and inclusion Engage in transparent and constructive conversations
DELIVER Drive results by inspiring and mobilizing people and teams. Empower people to act with speed, agility, and accountability
Demonstrate a global and enterprise-wide mindset Balance short and long-term strategic choices
LIVE OUR CREDO Demonstrate and inspire the behaviors that reinforce Our Credo. Serve as a role model for making Credo-based decisions Create a trusting, collaborative, and ethical work environment Maintain the highest standards of quality, compliance and accountability Champion programs and initiatives that support our environment and communities
J&J (China) Investments Ltd (7046)