Sr. Trial Initiation Specialist (Sr. TIS)

Sr. Trial Initiation Specialist (Sr. TIS)

06 Mar 2024
Pennsylvania, Northwales, 19454 Northwales USA

Sr. Trial Initiation Specialist (Sr. TIS)

Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.The Senior Trial Initiation Specialist in Global Site Budgets and Payments will be responsible for the following:

Preparation, execution and delivery of global clinical study site budgets (including all other relevant site budget deliverables) within Fair Market Value based upon protocol design, industry benchmark data and clinical trial team feedback.

Represent Global Site Budgets and Payments on Clinical Trial Teams during trial initiation as the single point of contact for budget development responsibilities.

Support Global Clinical Trial Operations with budget process expertise and study specific support to ensure global standardization of Global Site Budgets and Payments deliverables.

Analyze FMV/budget issues, obtain business partner input as needed, and provide risk assessments to expedite compliant resolution of complex budget/FMV issues in clinical trial contracting process.

Collaborate with Global Clinical Trial Operations to support continuous process improvement and compliance in the spirit of what is best for the business.

Track inquiries and monitor trends to identify need for additional standardized guidance and work with stakeholders to prepare such guidance for review/approval.

Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by GSBP management as well as our company’s guiding corporate policies.

Embrace the philosophy of holistic trial initiation support and streamline tasks to initiate trials within industry leading performance cycle times, unwavering quality and operational efficiency.

Oversight of subordinate personnel/activities.

Required Education:

A minimum of a bachelor's degree is required with a preferred area of study in a scientific discipline.

Required Experience and Skills:

Minimum of three (3) years of relevant experience in clinical research setting.

Business acumen and/ or financial background; preferably Investigator grants and payments.

Strong understanding and dedication to our company's Leadership principles, with an emphasis on relationship development, rapid decision making, conflict resolution, and team building instincts, with the ability to build partnerships and collaborate both internally and externally.

Strong collaboration and influencing skills to partner effectively across multiple groups.

Showing initiative in innovative approaches to challenges in a fast-paced, changing global environment.

Strong communication and presentation skills.

Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines which includes knowledge of Standard of Care/Routine Care and Fair Market Value principles.

Strong organization and prioritization skills.

Computer skills including proficiency in aspects of data analysis and presentation software, Microsoft Word and Excel.

Preferred Experience:

Medical billing and coding

MRLGCTONOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA Supplement​Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.Expected salary range:$111,400.00 - $175,300.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequisition ID: R284231

Job Details

Jocancy Online Job Portal by jobSearchi.