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Skills:

Research, Project Management, Compliance, English

Job type:

Full-time

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and 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 I ...
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).
• Identifies and shares best practices across clinical trials, countries, clusters.
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• As a customer-facing role, this position will build business relationships and represent company with investigators.
• Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
• Supports local and regional strategy development consistent with long term corporate needs in conjunction with CRD, TAH and Regional Operations.
• Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.
• WHAT YOU MUST HAVE.
• Bachelor's Degree in Science, Biology or equivalent. An advanced degree would be advantageous (e.g., Master's degree, MD, PhD).
• Minimum of 5 years' experience in clinical research.
• Knowledge in project management, site management and team management.
• Strong organizational skills with demonstrated success required.
• Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head or CRD.
• Requires strong understanding of local regulatory environment.
• Strong scientific and clinical research knowledge is required.
• Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
• Experience functioning as a key link between Country Operations and Clinical Trial Teams.
• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures, and functions.
• Ability and skills to manage resource allocation, processes (and controls), productivity, quality, and project delivery.
• Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking. Ability to work efficiently in a remote and virtual environment.
• Understand cultural diversity.
• The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring. Behavioral Competency Expectations: Strong leadership skills that enable and drive alignment with the goals, purpose, and mission of our Research & Development Division, Global Clinical Development (GCD) and GCTO.
• Ability to identify problems, conflicts, and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.
• low patient recruitment,.
• inadequate staff to meet business needs,.
• performance or compliance issues,.
• working with regulatory issues and the broader organization.
• resolution of conflictive situations.
• Educational/pedagogic, diplomatic, and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.
• We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
• Current Employees apply HERE.
• Current Contingent Workers apply HERE.
• 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.
• Regular
• No relocation
• Not Applicable
• 10/31/2024A 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:R316640.

Skills:

Compliance, Research, Excel, English

Job type:

Full-time

• Track (e.g. essential documents) and report (e.g. Safety Reports).
• Update clinical trial databases (CTMS) and trackers.
• Ensure collation and distribution of study tools and documents.
• Clinical supply & non-clinical supply management, in collaboration with other country roles.
• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable).
• Prepare documents and correspondence.
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF.
• Assist with eTMF reconciliation.
• Execute eTMF Quality Control Plan.
• Update manuals/documents (e.g., patient diaries, instructions).
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders.
• Obtain translations of documents.
• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions.
• Obtain, track and update study insurance certificates.
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Publish study results for GCTO and RA where required per local legislation.
• Ensure adherence to financial and compliance procedures.
• Monitor and track adherence and disclosures.
• Maintain tracking tools.
• Obtain and process FCPA documentation in a timely manner.
• Organize meetings (create & track study memos/letters/protocols).
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable).
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices.
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role.
• Excellent negotiation skills for CTCs in finance area.
• Effective time management, organizational and interpersonal skills, conflict management.
• Effective communication with external customers (e.g. sites and investigators).
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus, both internally and externally.
• Able to work independently.
• Proactive attitude to solving problems / proposing solutions.
• Positive mindset, growth mindset.
• Qualification & Experience:Bachelor s Degree (health sciences, healthcare preferred).
• Current Employees apply HERE.
• Current Contingent Workers apply HERE.
• 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.
• Regular
• Not Applicable
• 10/18/2024A 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:R308103.