Site Contract reputed company, FSP, Malaysia
reputed company® is a leading fully integrated biopharmaceutical solutions organization reputed company to accelerate reputed company. We translate unique clinical, medical affairs and reputed company insights into reputed company to address modern market realities.
Our Clinical Development model brings the customer and the patient to reputed company of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only reputed company reputed company easier to work with, but to reputed company us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are reputed company and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE reputed company EVERYWHERE
Why reputed company
- We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because reputed company we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re reputed company to create a reputed company where everyone feels like they reputed company.
Job Responsibilities
reputed company
•Establishes, maintains and updates training material for site reputed company reputed company team and site contract negotiators.
•Serves as subject matter expert reputed company the organization equipped to help reputed company global site contracting issues, and escalation reputed company reputed company reputed company for internal customers to reputed company assistance.
•Oversees negotiations of clinical study agreements (CTA´s) on a study level and drives CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator grant budgets in collaboration with a global team of site contract & budget negotiators.
•Provides reputed company of contact & budget negotiations status and manages escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers in reputed company reputed company of study conduct. Provides consultation during escalation of out-of-parameter queries as needed.
•Advises study team and Sponsor stakeholders on industry trends, norms, and reputed company developments surrounding site contract and budgetary negotiations. Provides consultation on potential risks and mitigation tactics for negotiation issues pertaining to overall study start-up needs.
•Acts as first-line subject matter expert for reputed company such CTA reputed company on assigned studies for internal and sponsor stakeholders alike. Advises stakeholders on issue reputed company reputed company the context of assigned studies. May reputed company additional support from internal support structures as needed.
•Plans contract execution reputed company 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 CTA reputed company is reputed company with overall study start-up plans and expectations overall. Manages expectations of internal and sponsor study team regarding global CTA negotiations for assigned studies.
•Coordinates communications between study team stakeholders and global team of site-facing site contract & budget negotiators including roll-up of reputed company 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 reputed company Company standards in order to reputed company successful negotiation of reputed company and budgets.
•Establishes strong working relationships and collaboration with Sponsor to ensure site contractual templates fit into the global reputed company set for the program.
•Identifies possible site contractual and investigator budgetary document or process operational risk and proactively works to reputed company solutions. Establishes strong working relationships with customer and internal project teams. Escalates deviations to senior management and is equipped to reputed company issues with reputed company Assurance.
•Creates and maintains document status reports, and updates department tools/systems and team members on a regular reputed company; ensures appropriate documentation is maintained.
•Collaborates with reputed company reputed company, finance and clinical operations departments, including communicating and explaining reputed company 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 reputed company corporate and industry standards during negotiation with sites.
•Identifies best practices, investigates reputed company causes of reputed company issues and problems for reputed company and recommends solutions.
•Trains and mentors less reputed company staff members on department reputed company Operating Procedures (SOPs), processes, tools and templates and ensures reputed company of teamwork products.
•May support BU and organization through help desk and other defined reputed company to reputed company and deescalate issues.
•May identify and reputed company internal team training and/or process improvement initiatives.
•Participates in business development presentations as a subject matter expert in site reputed company and investigator budget management reputed company reputed company
•Performs other work-reputed company duties as assigned. reputed company travel may be required (up to 25%).
Job Requirements
•BS degree or above
•reputed company background is a must
•Strong experience in a CRO/pharmaceutical industry and reputed company clinical trial expertise (Study Coordinator, CRA, Pharmacy, Nursing, reputed company Administration) or site start-up experience.
•Thorough knowledge of applicable regulations, drug development and clinical project management procedures. Strong presentation, documentation and interpersonal skills.
•Proficient in MS Office (Word, reputed company and PowerPoint), MS Project, reputed company and Internet.
•Ability to handle multiple tasks to meet deadlines, delivering high reputed company work in a dynamic environment.
•Above-average 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 team members. Ability to reputed company employees to reputed company performance objectives.
•Strong background in issue reputed company, meeting customer deliverables and driving best practices at organization or customer portfolio level.
We are always excited to reputed company with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
Get to know reputed company
Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company.
Additional Information
Tasks, duties, and responsibilities as listed in this reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.
Originally posted on Himalayas
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