Clinical Research Manager (CRM) – Infectious Disease (REMOTE)

Job Description

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our companys policies and procedures, quality standards and adverse event reporting requirements internally and externally.

The CRM could be responsible for a particular study for several countries in a cluster.

Responsibilities include, but are not limited to:

MainPointofContact(POC)forassignedprotocolsandlinkbetweenCountryOperations and clinical trial team (CTT).

Responsibleforprojectmanagementoftheassignedstudies:pro-activelyplans,drivesand tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.

Accountable for performance for assigned protocols in a country in compliance with ICH/GCPandcountryregulations, our companys policiesandprocedures,qualitystandardsand adverse event reporting requirements internally and externally.

ReviewsMonitoringVisitsReportsandescalatesperformanceissuesandtraining needs to CRA manager and/or functional vendor and internal management as needed.

PerformsQualitycontrolvisitsasrequired.

Leads local study teams to high performance: trains in the protocol other local roles, closely collaborateswithandsupportsCRAsasprotocolexpertandcoordinatesactivitiesacrossthe different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).

Responsibleforcreatingandexecutingalocalriskmanagementplanforassignedstudies.

EnsurescompliancewithCTMS,eTMFandotherkeysystemsinassignedstudies.

EscalatesasneededdifferentchallengesandissuestoTAHead/CRD/CCQMandorCTT (as appropriate).

Identifiesandsharesbestpracticesacrossclinicaltrials,countries,clusters.

Responsibleforcollaborationwithfunctionaloutsourcingvendors,investigators,other external partners in assigned studies.

CountryPOCforprogrammaticallyoutsourcedtrialsforassignedprotocols.

Asacustomer-facingrole,thispositionwillbuildbusinessrelationshipsandrepresentour Manufacturing Divisionwith investigators.

Serveslocalbusinessneedsasapplicableinhis/hercountry(ifdelegatedcansigncontracts and manage budgets).

Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD and Regional Operations.

Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance,GlobalMedicalAffairstoalignonkeyissues/decisions across the trials.Consult with our Human Health Divisionas needed.

Extent of Travel : Up to 30% of working time

CORE Competency Expectations:

KnowledgeinProjectManagementandsitemanagement.

Strongorganizationalskillswithdemonstratedsuccessrequired.

Requires ability to make decisions independently and oversee important activities relevanttoclinicalresearchactivitiesaccordingtopredeterminedglobalpoliciesand commitments with the support, oversight and supervision of the TA Head or CRD

Requiresstrongunderstandingoflocalregulatoryenvironment.

Strongscientificandclinicalresearchknowledgeisrequired.

Strongunderstandingofclinicaltrialplanning,managementandmetricsisessentialas well as the ability to focus on multiple deliverables and protocols simultaneously.

ExperiencefunctioningasakeylinkbetweenCountryOperationsandClinicalTrial Teams

Communicateseffectivelyandbuildsacollaborationspiritinaremote/virtualenvironment and across countries, cultures and functions.

Abilityandskillstomanageresourceallocation,processes(andcontrols),productivity, quality and project delivery.

ProficiencyinwrittenandspokenEnglishandlocallanguage.Theincumbentmustbe competent and effective in written and verbal communication.

Strategicthinking.

Abilitytoworkefficientlyinaremoteandvirtualenvironment.

Understandculturaldiversity.

Thepositionrequires provenstrongprojectmanagementskills and/or projectmanagement certification or relevant training program/close mentoring.

Behavioral Competency Expectations:

Strong leadership skills that enable and drive alignment with the goals, purpose and missionof our companys ResearchLabs,GlobalClinicalDevelopment(GCD)andGCTO.

Abilitytoidentifyproblems,conflictsandopportunitiesearlyandlead,analyzeand prepare mitigation plans and drive conflict resolution is critical.

Requiredtonegotiateskillfullyintoughsituationswithbothinternalandexternalgroups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or complianceissues,4)workingwithregulatoryissuesandthebroader organization,and5)resolutionofconflictivesituations.

Educational/pedagogic,diplomaticandempathicskillstoeffectivelybuildandmaintain professional relationships with investigators and other stakeholders.

Experience Requirements:

Required:

5yearsofexperienceinclinicalresearch

CRAExperiencepreferred

Trial management experience preferred

Educational Requirements:

Required:

BachelordegreeinScience(orcomparable)

​Preferred:

Advanceddegree,(e.g.,Masterdegree,MD,PhD)

Immunology or Infectious Diseases experience; specifically in HIV therapeutic area.

ResearchandDevelopmentDivisionGCTO

#eligibleforerp

NOTICE FOR INTERNAL APPLICANTS

In 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.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

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US and Puerto Rico Residents Only:

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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:

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U.S. Hybrid Work Model

Effective 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, Monday – 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

$135,500.00 – $213,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully

Merck & 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

10/21/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R317599